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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K971641
Device Name ANTIBACTERIAL GUTTA PERCHA
Applicant
Dr. Howard Martin, P.A.
4327 Reels Mill Rd.
Frederick,  MD  21704
Applicant Contact KYLE H SIBINOVIC
Correspondent
Dr. Howard Martin, P.A.
4327 Reels Mill Rd.
Frederick,  MD  21704
Correspondent Contact KYLE H SIBINOVIC
Regulation Number872.3850
Classification Product Code
EKM  
Date Received05/02/1997
Decision Date 07/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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