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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K955149
Device Name MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
Applicant
BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE,  CA  92614
Applicant Contact NICK HERBERT
Correspondent
BIO-MEDICAL DEVICES, INC.
1752-A LANGLEY AVE.
IRVINE,  CA  92614
Correspondent Contact NICK HERBERT
Regulation Number880.6740
Classification Product Code
BYY  
Date Received11/13/1995
Decision Date 01/24/1996
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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