The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Mwi 400 Wound Dressing.
Device ID | K874470 |
510k Number | K874470 |
Device Name: | MWI 400 WOUND DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
Contact | Dave Beattie |
Correspondent | Dave Beattie MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
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 | 1987-11-02 |
Decision Date | 1987-12-18 |