The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Aquaphor R Gauze.
| Device ID | K842967 |
| 510k Number | K842967 |
| Device Name: | AQUAPHOR R GAUZE |
| Classification | Dressing, Wound, Drug |
| Applicant | BEIERSDORF, INC. P.O. BOX 5529 Norwalk , CT 06856 - |
| Contact | John Trembley |
| Correspondent | John Trembley BEIERSDORF, INC. P.O. BOX 5529 Norwalk , CT 06856 - |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-27 |
| Decision Date | 1984-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05000223456573 | K842967 | 000 |
| 05000223456368 | K842967 | 000 |
| 05000223450229 | K842967 | 000 |
| 05000223450199 | K842967 | 000 |
| 05000223450168 | K842967 | 000 |
| 05000223450137 | K842967 | 000 |