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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K962683
Device Name SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
Applicant
Deknatel, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact DIANE E MINEAR, RAC
Correspondent
Deknatel, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact DIANE E MINEAR, RAC
Regulation Number884.1730
Classification Product Code
HIF  
Date Received07/10/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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