Name: Predicase
Price: 199 USD

K-number	K113088
Device name	HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Applicant	Innerspace, Inc.
Product code	GWM
Device class	Class II
Decision date	May 2, 2012
Decision	Substantially Equivalent
Regulation	882.1620

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Source

View the full FDA submission: accessdata.fda.gov

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HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)

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