The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Flexible Biopsy Cup Forceps.
| Device ID | K941158 |
| 510k Number | K941158 |
| Device Name: | FLEXIBLE BIOPSY CUP FORCEPS |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
| Contact | Laszlo Fazekas |
| Correspondent | Laszlo Fazekas SURGICAL TECHNOLOGIES, INC. 4715 N.W. 157TH ST., SUITE 212 Miami Lakes, FL 33014 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-04-28 |