Name: Predicase
Price: 199 USD

K-number	K050112
Device name	PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
Applicant	Prime Pacific Health Innovations Corporation
Product code	KPL
Device class	Class II
Decision date	Mar 15, 2005
Decision	Substantially Equivalent
Regulation	876.5220

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Source

View the full FDA submission: accessdata.fda.gov

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PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

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