The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Hot Biopsy Forceps.
| Device ID | K910964 |
| 510k Number | K910964 |
| Device Name: | HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes, FL 33014 |
| Contact | Kevin W Smith |
| Correspondent | Kevin W Smith SYMBIOSIS CORP. 5801 MIAMI LAKES DR. Miami Lakes, FL 33014 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-05-02 |