The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Dynabite Urological Forceps.
| Device ID | K952391 |
| 510k Number | K952391 |
| Device Name: | DYNABITE UROLOGICAL FORCEPS |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | PORTLYN CORP. ROUTE 25 Moultonboro, NH 03254 |
| Contact | George A Lyna |
| Correspondent | George A Lyna PORTLYN CORP. ROUTE 25 Moultonboro, NH 03254 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-06-01 |