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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K931338
Device Name 16 ELECTRODES (BLADE, BALL, NEEDLE & LOOP)
Applicant
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Applicant Contact ROBERT SARON
Correspondent
Aaron Medical Industries
1640 Central Ave.
St. Petersburg,  FL  33712
Correspondent Contact ROBERT SARON
Regulation Number884.4120
Classification Product Code
HGI  
Date Received03/16/1993
Decision Date 02/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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