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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 K011929
Device Name HANDPIECE SHEATH-MODEL #A910
Applicant
Aaron Medical, Inc.
7100- 30th Ave. N.
St. Petersburg,  FL  33710
Applicant Contact RICHARD KOZLOFF
Correspondent
Aaron Medical, Inc.
7100- 30th Ave. N.
St. Petersburg,  FL  33710
Correspondent Contact RICHARD KOZLOFF
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/20/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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