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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 K943954
Device Name ASPEN SURGICAL SYSTEMS INSUFFLATION TUBING SET WITH FILTER
Applicant
CONMED CORP.
3040 EAST RIVER RD.
DAYTON,  OH  45439
Applicant Contact IRA D DUESLER
Correspondent
CONMED CORP.
3040 EAST RIVER RD.
DAYTON,  OH  45439
Correspondent Contact IRA D DUESLER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/15/1994
Decision Date 11/15/1994
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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