Name: Predicase
Price: 199 USD

K-number	K935588
Device name	SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION
Applicant	Sudormed, Inc.
Product code	JKA
Device class	Class II
Decision date	Jul 14, 1995
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION

Everything you need for a 510(k) submission. Nothing you don't.