The following data is part of a premarket notification filed by William Feinstein & Associates, Inc. with the FDA for Antibacterial Adhesive Bandage.
Device ID | K992817 |
510k Number | K992817 |
Device Name: | ANTIBACTERIAL ADHESIVE BANDAGE |
Classification | Tape And Bandage, Adhesive (with Disinfectant) |
Applicant | WILLIAM FEINSTEIN & ASSOCIATES, INC. 330 EAST 75TH ST., SUITE 9F New York, NY 10021 |
Contact | William Feinstein |
Correspondent | William Feinstein WILLIAM FEINSTEIN & ASSOCIATES, INC. 330 EAST 75TH ST., SUITE 9F New York, NY 10021 |
Product Code | MXE |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-20 |
Decision Date | 1999-11-05 |