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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 K920114
Device Name CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
Applicant
Spiess Design, Inc.
495 Lindberg Ln.
Northbrook,  IL  60062
Applicant Contact DIETER KEPPEL
Correspondent
Spiess Design, Inc.
495 Lindberg Ln.
Northbrook,  IL  60062
Correspondent Contact DIETER KEPPEL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received01/10/1992
Decision Date 04/06/1992
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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