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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 K935588
Device Name SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION
Applicant
SUDORMED, INC.
12341 NEWPORT AVE., #D-200
SANTA ANA,  CA  92705
Applicant Contact JON BOOHER
Correspondent
SUDORMED, INC.
12341 NEWPORT AVE., #D-200
SANTA ANA,  CA  92705
Correspondent Contact JON BOOHER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/17/1993
Decision Date 07/14/1995
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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