The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Envisan Paste.
| Device ID | K874553 |
| 510k Number | K874553 |
| Device Name: | ENVISAN PASTE |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| 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 | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1987-12-18 |