The following data is part of a premarket notification filed by John M. Rayhack with the FDA for Fixation Devices And Bone Plate.
Device ID | K913930 |
510k Number | K913930 |
Device Name: | FIXATION DEVICES AND BONE PLATE |
Classification | Plate, Fixation, Bone |
Applicant | JOHN M. RAYHACK 13919 SHADY SHORES DR. Tampa, FL 33613 |
Contact | John M Rayhack |
Correspondent | John M Rayhack JOHN M. RAYHACK 13919 SHADY SHORES DR. Tampa, FL 33613 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-22 |
Decision Date | 1991-10-04 |