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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K900755
Device Name DIGITAL CUFF PV GAUGE
Applicant
INTERNATIONAL MEDICAL PRODUCTS, INC.
P.O. BOX 5162
6821 SUTHERLAND COURT
MENTOR,  OH  44060
Applicant Contact NAYAN S SHAH
Correspondent
INTERNATIONAL MEDICAL PRODUCTS, INC.
P.O. BOX 5162
6821 SUTHERLAND COURT
MENTOR,  OH  44060
Correspondent Contact NAYAN S SHAH
Regulation Number868.5750
Classification Product Code
BSK  
Date Received02/16/1990
Decision Date 04/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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