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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K940425
Device Name IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
Applicant
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Applicant Contact GUY R LOWERY
Correspondent
Imagyn Medical, Inc.
27651 La Paz Rd.
Laguna Niguel,  CA  92656
Correspondent Contact GUY R LOWERY
Regulation Number870.1650
Classification Product Code
MAV  
Date Received01/31/1994
Decision Date 08/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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