Name: Predicase
Price: 199 USD

K-number	K891460
Device name	NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE
Applicant	Smith & Nephew United, Inc.
Product code	EFQ
Device class	Class U
Decision date	Apr 17, 1989
Decision	Substantially Equivalent for Some Indications
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE

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