The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Dynabite Hot Gi Biopsy Forceps.
| Device ID | K970083 |
| 510k Number | K970083 |
| Device Name: | DYNABITE HOT GI BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | PORTLYN CORP. RFD #1 BOX 451, ROUTE 25 Moultonboro, NH 03254 |
| Contact | George A Lyna |
| Correspondent | George A Lyna PORTLYN CORP. RFD #1 BOX 451, ROUTE 25 Moultonboro, NH 03254 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-06-17 |
| Summary: | summary |