K-number	K802647
Device name	ECA GEL PROUDUCT REFORMULATION
Applicant	Vanaray Laboratories, Inc.
Product code	GYB
Device class	Class II
Decision date	Jan 8, 1981
Decision	Substantially Equivalent
Regulation	882.1275

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View the full FDA submission: accessdata.fda.gov

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ECA GEL PROUDUCT REFORMULATION

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