The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for Laceration Tray.
Device ID | K932036 |
510k Number | K932036 |
Device Name: | LACERATION TRAY |
Classification | Wrap, Sterilization |
Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
Contact | Patricia Stawarz |
Correspondent | Patricia Stawarz CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-27 |
Decision Date | 1993-12-13 |