K-number	K143434
Device name	One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
Applicant	Abbott Medical Optics, Inc.
Product code	MSS
Device class	Class I
Decision date	May 6, 2015
Decision	Substantially Equivalent
Regulation	886.4300

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View the full FDA submission: accessdata.fda.gov

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One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series

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