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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 K913623
Device Name SURGICAL ELECTRICAL PENCIL
Applicant
Aaron Medical, Inc.
1640 Central Ave.
St. Petersburg,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical, Inc.
1640 Central Ave.
St. Petersburg,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/13/1991
Decision Date 02/21/1992
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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