The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Cerclage Wire Crimp Sleeve.
Device ID | K931246 |
510k Number | K931246 |
Device Name: | CERCLAGE WIRE CRIMP SLEEVE |
Classification | Cerclage, Fixation |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | JDQ |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-11 |
Decision Date | 1994-02-22 |