K-number	K963177
Device name	TED 191
Applicant	Teledyne Brown Engineering
Product code	CCL
Device class	Class II
Decision date	Nov 13, 1997
Decision	Substantially Equivalent
Regulation	868.1720

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Source

View the full FDA submission: accessdata.fda.gov

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TED 191

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