The following data is part of a premarket notification filed by General Hospital Supply Corp. with the FDA for Instrument Tray Liner.
Device ID | K971217 |
510k Number | K971217 |
Device Name: | INSTRUMENT TRAY LINER |
Classification | Tray, Surgical, Instrument |
Applicant | GENERAL HOSPITAL SUPPLY CORP. 196 DANBURY RD. Wilton, CT 06897 |
Contact | Phillip Davis |
Correspondent | Phillip Davis GENERAL HOSPITAL SUPPLY CORP. 196 DANBURY RD. Wilton, CT 06897 |
Product Code | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-02 |
Decision Date | 1997-05-06 |