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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, collagen
510(k) Number K122115
Device Name COLLAGEN DENTAL WOUND DRESSINGS
Original Applicant
COLLAGEN MATRIX, INC.
15 thornton road
oakland,  NJ  07436
Original Contact peggy hansen
Classification Product Code
KGN  
Date Received07/17/2012
Decision Date 11/01/2012
Decision substantially equivalent (SE)
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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