Name: Predicase
Price: 199 USD

K-number	K951878
Device name	SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
Applicant	General Surgical Innovations
Product code	GCJ
Device class	Class II
Decision date	Jun 29, 1995
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA

Everything you need for a 510(k) submission. Nothing you don't.