The following data is part of a premarket notification filed by Cooper Surgical/aesthete with the FDA for Areola/nipple Dressing.
| Device ID | K882558 |
| 510k Number | K882558 |
| Device Name: | AREOLA/NIPPLE DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | COOPER SURGICAL/AESTHETE POST OFFICE BOX 278 634 AIRPORT ROAD Paso Robles, CA 93447 |
| Contact | Thomas D Salisbury |
| Correspondent | Thomas D Salisbury COOPER SURGICAL/AESTHETE POST OFFICE BOX 278 634 AIRPORT ROAD Paso Robles, CA 93447 |
| 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 | 1988-06-21 |
| Decision Date | 1989-05-24 |