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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K955896
Device Name MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
Applicant
Critical Device Corp.
499 Nibus St.
Brea,  CA  92621
Applicant Contact SUSAN D GOLDSETIN-FALK
Correspondent
Critical Device Corp.
499 Nibus St.
Brea,  CA  92621
Correspondent Contact SUSAN D GOLDSETIN-FALK
Regulation Number880.5440
Classification Product Code
LHI  
Date Received12/29/1995
Decision Date 02/06/1996
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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