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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K945764
Device Name HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP
Applicant
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Applicant Contact J R SARON
Correspondent
Aaron Medical Industries
7100 30th Ave. N
St. Petersburg,  FL  33710
Correspondent Contact J R SARON
Regulation Number876.4300
Classification Product Code
KNS  
Date Received11/01/1994
Decision Date 01/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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