The following data is part of a premarket notification filed by Winfield Laboratories, Inc. with the FDA for Kontour Ultra Soft Sponge #ss144.50.
| Device ID | K872069 |
| 510k Number | K872069 |
| Device Name: | KONTOUR ULTRA SOFT SPONGE #SS144.50 |
| Classification | Dressing, Wound, Drug |
| Applicant | WINFIELD LABORATORIES, INC. 1303 COLUMBIA SUITE 207 Richardson, TX 75081 |
| Contact | Robert Cummings |
| Correspondent | Robert Cummings WINFIELD LABORATORIES, INC. 1303 COLUMBIA SUITE 207 Richardson, TX 75081 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-29 |
| Decision Date | 1987-07-14 |