The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Dynabite Laparoscopic Forceps.
| Device ID | K944245 |
| 510k Number | K944245 |
| Device Name: | DYNABITE LAPAROSCOPIC 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 | 1994-08-30 |
| Decision Date | 1994-11-15 |