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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K844475
Device Name SPECIMEN COLLECTION & TRANSPORT SYSTEM
Applicant
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Applicant Contact WARREN R SANBORN
Correspondent
Portable Medical Laboratories, Inc.
P.O. Box 667
Solana Beach,  CA  92075
Correspondent Contact WARREN R SANBORN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/19/1984
Decision Date 02/06/1985
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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