The following data is part of a premarket notification filed by Johnson & Johnson Patient Care, Inc. with the FDA for Nu-derm Hydrocolloid Dressing.
| Device ID | K890545 |
| 510k Number | K890545 |
| Device Name: | NU-DERM HYDROCOLLOID DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON PATIENT CARE, INC. New Brunswick, NJ 08903 |
| Contact | Omega Norton-crable |
| Correspondent | Omega Norton-crable JOHNSON & JOHNSON PATIENT CARE, INC. New Brunswick, NJ 08903 |
| 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 | 1989-02-03 |
| Decision Date | 1989-03-23 |