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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 K923194
Device Name INSUFFLATOR CONNECTING FILTER
Applicant
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Applicant Contact MADALYN C DUNCAN
Correspondent
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Correspondent Contact MADALYN C DUNCAN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received06/30/1992
Decision Date 10/08/1993
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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