The following data is part of a premarket notification filed by Johnson & Johnson Patient Care, Inc. with the FDA for Actisorb* Plus Activated Charcoal Dress W/silver.
Device ID | K892851 |
510k Number | K892851 |
Device Name: | ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER |
Classification | Dressing, Wound, Drug |
Applicant | JOHNSON & JOHNSON PATIENT CARE, INC. New Brunswick, NJ 08903 |
Contact | Richard J Skalski |
Correspondent | Richard J Skalski 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 | 1989-04-18 |
Decision Date | 1989-09-26 |