The following data is part of a premarket notification filed by Professional Medical Products, Inc. with the FDA for Aegis Non-adherent Dressing.
| Device ID | K820413 |
| 510k Number | K820413 |
| Device Name: | AEGIS NON-ADHERENT DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | PROFESSIONAL MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| 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 | 1982-02-12 |
| Decision Date | 1982-03-12 |