The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Dispos Gastro Biopsy Forceps W/reuse Han.
Device ID | K932266 |
510k Number | K932266 |
Device Name: | SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN |
Classification | Forceps, Biopsy, Electric |
Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Contact | Kevin W Smith |
Correspondent | Kevin W Smith SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
Product Code | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-20 |
Decision Date | 1994-03-15 |