The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Actisorb Activated Charcoal Dressing.
| Device ID | K860486 |
| 510k Number | K860486 |
| Device Name: | ACTISORB ACTIVATED CHARCOAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Mark Citron |
| Correspondent | Mark Citron 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 | 1986-02-10 |
| Decision Date | 1986-03-26 |