K-number	K900251
Device name	REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
Applicant	Helena Laboratories
Product code	CEF
Device class	Class I
Decision date	Feb 26, 1990
Decision	Substantially Equivalent
Regulation	862.1630

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REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175

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