The following data is part of a premarket notification filed by Premier Medical with the FDA for Biopsy Punch.
Device ID | K896303 |
510k Number | K896303 |
Device Name: | BIOPSY PUNCH |
Classification | Punch, Surgical |
Applicant | PREMIER MEDICAL 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
Contact | Robert E Regan |
Correspondent | Robert E Regan PREMIER MEDICAL 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19404 |
Product Code | LRY |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1990-02-13 |