The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Hydradjust Iv Urological Table.
Device ID | K943581 |
510k Number | K943581 |
Device Name: | HYDRADJUST IV UROLOGICAL TABLE |
Classification | Table, Radiographic, Tilting |
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 | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-22 |
Decision Date | 1995-01-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10746190002451 | K943581 | 000 |
10746190002444 | K943581 | 000 |