K-number	K971292
Device name	JEL-71 PDF
Applicant	J.F. Jelenko & Co., Inc.
Product code	EJT
Device class	Class II
Decision date	May 20, 1997
Decision	Substantially Equivalent
Regulation	872.3060

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View the full FDA submission: accessdata.fda.gov

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JEL-71 PDF

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