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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 K931742
Device Name INJECT-R FILL
Applicant
Union Broach, Div. Moyco Industries, Inc.
P.O. Box 508
Aberdeen Rd.
Emigsville,  PA  17318
Applicant Contact CHRIS M LEHR
Correspondent
Union Broach, Div. Moyco Industries, Inc.
P.O. Box 508
Aberdeen Rd.
Emigsville,  PA  17318
Correspondent Contact CHRIS M LEHR
Regulation Number872.3850
Classification Product Code
EKM  
Date Received04/07/1993
Decision Date 05/27/1993
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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