REESE OSTEOTOMY GUIDE SYS

Protractor

OSTEOTOMY GUIDE CO.

The following data is part of a premarket notification filed by Osteotomy Guide Co. with the FDA for Reese Osteotomy Guide Sys.

Pre-market Notification Details

Device IDK841470
510k NumberK841470
Device Name:REESE OSTEOTOMY GUIDE SYS
ClassificationProtractor
Applicant OSTEOTOMY GUIDE CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHTH  
CFR Regulation Number888.4600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-09
Decision Date1984-05-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.