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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 K971674
Device Name VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST
Applicant
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Applicant Contact J. ROBERT SARON
Correspondent
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Correspondent Contact J. ROBERT SARON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/07/1997
Decision Date 06/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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