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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 K851096
Device Name HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
Applicant
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Applicant Contact DAVID BARLOW
Correspondent
OLYMPUS CORP.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042
Correspondent Contact DAVID BARLOW
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/19/1985
Decision Date 05/22/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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