K-number	K910755
Device name	PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
Applicant	Intermedics Orthopedics
Product code	MEH
Device class	Class II
Decision date	Mar 26, 1991
Decision	Substantially Equivalent
Regulation	888.3353

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View the full FDA submission: accessdata.fda.gov

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PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

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