Name: Predicase
Price: 199 USD

K-number	K122840
Device name	CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Applicant	Mick Radio-Nuclear Instruments, Inc.
Product code	JAQ
Device class	Class II
Decision date	Dec 14, 2012
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407

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