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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Heart-Valve Movement, Fetal, Ultrasonic
510(k) Number K910982
Device Name INNERVISION IRRIGATION PUMP
Applicant
M.D. Engineering, Inc.
2536 Barrington Court
Hayward,  CA  94545
Applicant Contact ANDREW HALSEY
Correspondent
M.D. Engineering, Inc.
2536 Barrington Court
Hayward,  CA  94545
Correspondent Contact ANDREW HALSEY
Regulation Number884.2660
Classification Product Code
HEI  
Date Received03/07/1991
Decision Date 08/26/1991
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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