K-number	K912386
Device name	REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
Applicant	Helena Laboratories
Product code	CEF
Device class	Class I
Decision date	Jul 17, 1991
Decision	Substantially Equivalent
Regulation	862.1630

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REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165

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