The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Enviclusive (tm).
| Device ID | K874554 |
| 510k Number | K874554 |
| Device Name: | ENVICLUSIVE (TM) |
| Classification | Dressing, Wound, Drug |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | William H Guinty |
| Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| 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 | 1987-11-04 |
| Decision Date | 1988-03-11 |