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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K932276
Device Name CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020
Applicant
KARL STORZ Endoscopy-America, Inc.
1201 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact PAUL L SUMNER
Correspondent
KARL STORZ Endoscopy-America, Inc.
1201 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact PAUL L SUMNER
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/12/1993
Decision Date 02/28/1995
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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