Name: Predicase
Price: 199 USD

K-number	K984211
Device name	MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303
Applicant	Medscand AB
Product code	HIB
Device class	Class II
Decision date	Dec 23, 1998
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

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