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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 K921468
Device Name PERMAMESH HYDROXYLAPATITE MATRIX
Applicant
CERAMED CORP.
12860 WEST CEDAR DRIVE,
SUITE 108
LAKEWOOD,  CO  80228
Applicant Contact BARBARA A WATSON
Correspondent
CERAMED CORP.
12860 WEST CEDAR DRIVE,
SUITE 108
LAKEWOOD,  CO  80228
Correspondent Contact BARBARA A WATSON
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/27/1992
Decision Date 08/21/1992
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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