The following data is part of a premarket notification filed by Aap International, Ltd. with the FDA for Aap Bone Plate.
Device ID | K915315 |
510k Number | K915315 |
Device Name: | AAP BONE PLATE |
Classification | Plate, Fixation, Bone |
Applicant | AAP INTERNATIONAL, LTD. 420 ROUTE 206 NORTH, SUITE 200 Bedminster, NJ 07921 |
Contact | Wayne R Knupp |
Correspondent | Wayne R Knupp AAP INTERNATIONAL, LTD. 420 ROUTE 206 NORTH, SUITE 200 Bedminster, NJ 07921 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-22 |
Decision Date | 1992-02-20 |