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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dermatome
510(k) Number K861138
Device Name MASH DERMATOME
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 Number878.4820
Classification Product Code
GFD  
Date Received03/26/1986
Decision Date 04/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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