K-number	K952278
Device name	THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA
Applicant	General Surgical Innovations
Product code	GCJ
Device class	Class II
Decision date	Aug 7, 1995
Decision	Substantially Equivalent
Regulation	876.1500

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View the full FDA submission: accessdata.fda.gov

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THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULA

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