The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Biopsy Forceps.
| Device ID | K901300 |
| 510k Number | K901300 |
| Device Name: | BIOPSY FORCEPS |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | PORTLYN CORP. RFD 1, BOX 451 ROUTE 25 Moultonboro, NH 03254 |
| Contact | Kenneth V Freeman |
| Correspondent | Kenneth V Freeman PORTLYN CORP. RFD 1, BOX 451 ROUTE 25 Moultonboro, NH 03254 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-20 |
| Decision Date | 1990-06-29 |