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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 K864395
Device Name LOW VOLUME EXTENSION SET
Applicant
Panamedix, Inc.
1308-E Logan Ave.
Costa Mesa,  CA  92626
Applicant Contact CARL JOHNSTON
Correspondent
Panamedix, Inc.
1308-E Logan Ave.
Costa Mesa,  CA  92626
Correspondent Contact CARL JOHNSTON
Regulation Number880.5440
Classification Product Code
FPK  
Date Received11/06/1986
Decision Date 12/16/1986
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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