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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K915315
Device Name AAP BONE PLATE
Applicant
Aap International, Ltd.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Applicant Contact WAYNE R KNUPP
Correspondent
Aap International, Ltd.
420 Rte. 206 N., Suite 200
Bedminster,  NJ  07921
Correspondent Contact WAYNE R KNUPP
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/22/1991
Decision Date 02/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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