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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Photographic, Fiberoptic
510(k) Number K844774
Device Name EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
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 Number876.1500
Classification Product Code
FCR  
Date Received12/10/1984
Decision Date 04/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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