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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cautery, Thermal, Ac-Powered
510(k) Number K844775
Device Name EFFNER-EYE CAUTERY WITH BATTERY HANDLE
Applicant
Mecron Medical Products, Inc.
938 Port Washington Blvd.
P.O. Box 1139
Port Washington,  NY  11050
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Mecron Medical Products, Inc.
938 Port Washington Blvd.
P.O. Box 1139
Port Washington,  NY  11050
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number886.4115
Classification Product Code
HQO  
Date Received12/10/1984
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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