The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Johnson & Johnson Petrolatum Gauze Non Adher Dress.
| Device ID | K862163 |
| 510k Number | K862163 |
| Device Name: | JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Omega Norton-crable |
| Correspondent | Omega Norton-crable JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| 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 | 1986-06-06 |
| Decision Date | 1986-07-09 |