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 |