The following data is part of a premarket notification filed by Osteotomy Guide Co. with the FDA for Reese Osteotomy Guide Sys.
Device ID | K841470 |
510k Number | K841470 |
Device Name: | REESE OSTEOTOMY GUIDE SYS |
Classification | Protractor |
Applicant | OSTEOTOMY GUIDE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTH |
CFR Regulation Number | 888.4600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-09 |
Decision Date | 1984-05-23 |