HYDRAGOWN
Gown, Surgical
MALLINCKRODT GROUP, INC.
The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydragown.
Pre-market Notification Details
| Device ID | K934664 |
| 510k Number | K934664 |
| Device Name: | HYDRAGOWN |
| Classification | Gown, Surgical |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | M. L. Friedman |
| Correspondent | M. L. Friedman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-28 |
| Decision Date | 1994-05-24 |
Trademark Results [HYDRAGOWN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDRAGOWN 74276810 1814394 Dead/Cancelled |
Liebel-Flarsheim Company 1992-05-18 |
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