The following data is part of a premarket notification filed by Absorbent Cotton Co., Inc. with the FDA for Oil Emulsion Non-adhering Dressing.
| Device ID | K850126 |
| 510k Number | K850126 |
| Device Name: | OIL EMULSION NON-ADHERING DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ABSORBENT COTTON CO., INC. FOURTH AND MARSHALL ST. Valley Park, MO 63088 |
| Contact | Cutright |
| Correspondent | Cutright ABSORBENT COTTON CO., INC. FOURTH AND MARSHALL ST. Valley Park, MO 63088 |
| 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 | 1985-01-14 |
| Decision Date | 1985-04-25 |