The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Dynabite Hysteroscopic Forceps.
Device ID | K934506 |
510k Number | K934506 |
Device Name: | DYNABITE HYSTEROSCOPIC FORCEPS |
Classification | Laparoscope, Gynecologic (and Accessories) |
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 | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-14 |
Decision Date | 1994-03-22 |