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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K960267
Device Name TBM SPONGE
Applicant
BIOCOLL LABORATORIES, INC.
1247 FLORIDA AVE.
PALM HARBOR,  FL  34683
Applicant Contact ED RANSON
Correspondent
BIOCOLL LABORATORIES, INC.
1247 FLORIDA AVE.
PALM HARBOR,  FL  34683
Correspondent Contact ED RANSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/18/1996
Decision Date 11/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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