The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Euro-med Light Touch Biopsy Punch.
Device ID | K884740 |
510k Number | K884740 |
Device Name: | EURO-MED LIGHT TOUCH BIOPSY PUNCH |
Classification | Punch, Biopsy, Surgical |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | EME |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1989-03-06 |