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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K915065
Device Name I.V.IRRIGATION POLE
Applicant
AMERICAN MEDICAL MFG., INC.
22231 MULHOLLAND HWY.
CALABASAS,  CA  91302
Applicant Contact MIKE HOFTMAN
Correspondent
AMERICAN MEDICAL MFG., INC.
22231 MULHOLLAND HWY.
CALABASAS,  CA  91302
Correspondent Contact MIKE HOFTMAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received11/08/1991
Decision Date 02/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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