The following data is part of a premarket notification filed by Wiltek Medical, Inc. with the FDA for Wiltek Hot Biopsy Forceps.
| Device ID | K990231 |
| 510k Number | K990231 |
| Device Name: | WILTEK HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | WILTEK MEDICAL, INC. 101 NORTH CHESTNUT ST., #300 Winston-salem, NC 27101 |
| Contact | Jon S Wilson |
| Correspondent | Jon S Wilson WILTEK MEDICAL, INC. 101 NORTH CHESTNUT ST., #300 Winston-salem, NC 27101 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-25 |
| Decision Date | 1999-04-13 |