Name: Predicase
Price: 199 USD

K-number	K120284
Device name	DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
Applicant	Coloplast A/S
Product code	NEW
Device class	Class II
Decision date	May 23, 2012
Decision	Substantially Equivalent
Regulation	878.4840

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Source

View the full FDA submission: accessdata.fda.gov

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DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

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