K-number	K973316
Device name	REP SPE VIS-60/40 KIT
Applicant	Helena Laboratories
Product code	CEF
Device class	Class I
Decision date	Oct 1, 1997
Decision	Substantially Equivalent
Regulation	862.1630

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View the full FDA submission: accessdata.fda.gov

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REP SPE VIS-60/40 KIT

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