The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Envisan Pad.
Device ID | K874552 |
510k Number | K874552 |
Device Name: | ENVISAN PAD |
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 | 1988-01-22 |