The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Biopsy Forcep (non-electric).
| Device ID | K896147 |
| 510k Number | K896147 |
| Device Name: | BIOPSY FORCEP (NON-ELECTRIC) |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | PORTLYN CORP. RFD 1, BOX 451 ROUTE 25 Moultonboro, NH 03254 |
| Contact | Joseph Skorupa |
| Correspondent | Joseph Skorupa PORTLYN CORP. RFD 1, BOX 451 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 | 1989-10-23 |
| Decision Date | 1990-04-16 |