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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 K861041
Device Name ENHANCE
Applicant
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Applicant Contact ROBERT FAIR
Correspondent
Packaging Technologies, Inc.
262 Gemini Ave.
Brea,  CA  92621
Correspondent Contact ROBERT FAIR
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/18/1986
Decision Date 05/30/1986
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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