Section 22-B10500. WHO MUST REGISTER AND SUBMIT A DEVICE LIST

Section 22-B10501. TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING

Section 22-B10502. HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES

Section 22-B10503. INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING

Section 22-B10504. AMENDMENTS TO ESTABLISHMENT REGISTRATION

Section 22-B10505. UPDATING DEVICE LISTING INFORMATION

Section 22-B10506. ADDITIONAL LISTING INFORMATION

Section 22-B10507. NOTIFICATION OF REGISTRANT

Section 22-B10508. INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING

Section 22-B10509. MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER

Section 22-B10510. ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES

Section 22-B10511. EXEMPTIONS FOR DEVICE ESTABLISHMENTS

Section 22-B10512. WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED

Section 22-B10513. EXEMPTION FROM PREMARKET NOTIFICATION

Section 22-B10514. INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION

Section 22-B10515. FORMAT OF A PREMARKET NOTIFICATION SUBMISSION

Section 22-B10516. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) SUMMARY

Section 22-B10517. CONTENT AND FORMAT OF A 21 U.S.C. § 360(K) STATEMENT

Section 22-B10518. FORMAT OF A CLASS III CERTIFICATION

Section 22-B10519. CONFIDENTIALITY OF INFORMATION

Section 22-B10520. MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION

Section 22-B10521. DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION

Section 22-B10599. DEFINITIONS