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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K936240
Device Name SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
Applicant
Sudormed, Inc.
12341 Newport Ave., #D-200
Santa Ana,  CA  92705
Applicant Contact JON BOOHER, PH.D
Correspondent
Sudormed, Inc.
12341 Newport Ave., #D-200
Santa Ana,  CA  92705
Correspondent Contact JON BOOHER, PH.D
Regulation Number862.1675
Classification Product Code
JKA  
Date Received12/30/1993
Decision Date 03/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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