K-number	K883690
Device name	ORTHO FACTOR X DEFICIENT PLASMA
Applicant	Ortho Diagnostic Systems, Inc.
Product code	GJT
Device class	Class II
Decision date	Nov 1, 1988
Decision	Substantially Equivalent
Regulation	864.7290

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View the full FDA submission: accessdata.fda.gov

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ORTHO FACTOR X DEFICIENT PLASMA

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