The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Symbiosis Gastrointestinal Biopsy Forceps.
| Device ID | K946238 |
| 510k Number | K946238 |
| Device Name: | SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Non-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 | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-01-20 |