The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Gynecological Biopsy Forceps.
Device ID | K930773 |
510k Number | K930773 |
Device Name: | SYMBIOSIS GYNECOLOGICAL BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Gynecological |
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 | HFB |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-16 |
Decision Date | 1994-07-28 |