The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Percutaneous 3mm Half-pins.
Device ID | K875013 |
510k Number | K875013 |
Device Name: | ACE PERCUTANEOUS 3MM HALF-PINS |
Classification | Pin, Fixation, Threaded |
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 | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-04 |
Decision Date | 1988-01-14 |