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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 K052041
Device Name COLLAGEN BONE HEALING PROTECTIVE SHEET
Applicant
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
COLLAGEN MATRIX, INC.
509 COMMERCE ST.
FRANKLIN LAKES,,  NJ  07417
Correspondent Contact PEGGY HANSEN
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
FTM   LZN  
Date Received07/28/2005
Decision Date 10/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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