The following data is part of a premarket notification filed by Geny Medical, Inc. with the FDA for Mini-h-fixation.
Device ID | K792561 |
510k Number | K792561 |
Device Name: | MINI-H-FIXATION |
Classification | Component, Traction, Invasive |
Applicant | GENY MEDICAL, INC. 66 ARGONAUT # 170 Aliso Viejo, CA 92656 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-12 |
Decision Date | 1979-12-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327079784 | K792561 | 000 |
07613327079746 | K792561 | 000 |
07613327079708 | K792561 | 000 |
07613327079692 | K792561 | 000 |
07613327079685 | K792561 | 000 |
07613327079678 | K792561 | 000 |
07613327079661 | K792561 | 000 |