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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K952243
Device Name EXTENSION SET/I.V. SET
Applicant
Coast Medical, Inc.
1060 N. Batavia
Unit H
Orange,  CA  92667
Applicant Contact TIM L TRUITT
Correspondent
Coast Medical, Inc.
1060 N. Batavia
Unit H
Orange,  CA  92667
Correspondent Contact TIM L TRUITT
Regulation Number880.5440
Classification Product Code
FPK  
Date Received05/12/1995
Decision Date 07/26/1995
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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