The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Aim - Cpm Hand Unit.
Device ID | K860714 |
510k Number | K860714 |
Device Name: | ACE AIM - CPM HAND UNIT |
Classification | Exerciser, Finger, Powered |
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 | JFA |
CFR Regulation Number | 890.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-03-27 |