The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for Punch Biopsy Kit.
Device ID | K862562 |
510k Number | K862562 |
Device Name: | PUNCH BIOPSY KIT |
Classification | Instrument, Biopsy |
Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
Contact | Sidney Finkelstein |
Correspondent | Sidney Finkelstein CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-03 |
Decision Date | 1986-10-07 |