K-number	K011183
Device name	OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
Applicant	Advanced Surgical Concepts (Asc)
Product code	GCJ
Device class	Class II
Decision date	Jun 15, 2001
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE

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