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 |