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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 K922038
Device Name CO2 INSUFFLATION TUBING
Applicant
Surgeon Surgical Instrumentation, Inc.
1030 Richfield Rd.
Placentia,  CA  92670
Applicant Contact DON W HAAR
Correspondent
Surgeon Surgical Instrumentation, Inc.
1030 Richfield Rd.
Placentia,  CA  92670
Correspondent Contact DON W HAAR
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/01/1992
Decision Date 10/13/1992
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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