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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 K910983
Device Name IV 1000 INSUFFLATOR RAPID FLOW
Applicant
M.D. Engineering, Inc.
2536 Barrington Ct.
Hayward,  CA  94545
Applicant Contact ANDREW HALSEY
Correspondent
M.D. Engineering, Inc.
2536 Barrington Ct.
Hayward,  CA  94545
Correspondent Contact ANDREW HALSEY
Regulation Number884.1730
Classification Product Code
HIF  
Date Received03/07/1991
Decision Date 12/09/1991
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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