The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Non-adhering Dressing With Povidone-iodine.
| Device ID | K861384 |
| 510k Number | K861384 |
| Device Name: | NON-ADHERING DRESSING WITH POVIDONE-IODINE |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Orville W Ostmann |
| Correspondent | Orville W Ostmann JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| 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 | 1986-04-14 |
| Decision Date | 1986-07-01 |