The following data is part of a premarket notification filed by International Hospital Supply Co. with the FDA for Forceps, Coagulation, Bipolar, Malis.
Device ID | K911377 |
510k Number | K911377 |
Device Name: | FORCEPS, COAGULATION, BIPOLAR, MALIS |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
Contact | George O Shecter |
Correspondent | George O Shecter INTERNATIONAL HOSPITAL SUPPLY CO. 18321 VENTURA BLVD. #1010 Tarzana, CA 91356 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-28 |
Decision Date | 1991-04-19 |