K-number	K901463
Device name	REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
Applicant	Helena Laboratories
Product code	JQJ
Device class	Class I
Decision date	Jun 12, 1990
Decision	Substantially Equivalent
Regulation	862.1630

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View the full FDA submission: accessdata.fda.gov

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REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)

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