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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mirror, Mouth
510(k) Number K941574
Device Name RETRO MIRROR
Applicant
Union Broach, Div. Moyco Industries, Inc.
Division Of Moyco Ind., Inc.
P.O. Box 508, Aberdeen Rd.
Emigsville,  PA  17318
Applicant Contact CHRIS M LEHR
Correspondent
Union Broach, Div. Moyco Industries, Inc.
Division Of Moyco Ind., Inc.
P.O. Box 508, Aberdeen Rd.
Emigsville,  PA  17318
Correspondent Contact CHRIS M LEHR
Regulation Number872.4565
Classification Product Code
EAX  
Date Received03/31/1994
Decision Date 05/18/1994
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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