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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K931537
Device Name A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
Applicant
Alto Development Corp.
5012 Asbury Rd.
P.O. Box 758
Farmingdale,  NJ  07727
Applicant Contact TIM WOJCIECHOWICZ
Correspondent
Alto Development Corp.
5012 Asbury Rd.
P.O. Box 758
Farmingdale,  NJ  07727
Correspondent Contact TIM WOJCIECHOWICZ
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/29/1993
Decision Date 09/07/1993
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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