The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Instrument, Manual, General Surgical.
Device ID | K925707 |
510k Number | K925707 |
Device Name: | INSTRUMENT, MANUAL, GENERAL SURGICAL |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Contact | Thomas O Bales |
Correspondent | Thomas O Bales SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-12 |
Decision Date | 1993-05-26 |