Name: Predicase
Price: 199 USD

K-number	K980673
Device name	SPYROSORB FOAM ISLAND WOUND DRESSING
Applicant	Innovative Technologies (Us), Inc.
Product code	KMF
Device class	Class I
Decision date	May 21, 1998
Decision	Substantially Equivalent for Some Indications
Regulation	880.5090

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Source

View the full FDA submission: accessdata.fda.gov

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SPYROSORB FOAM ISLAND WOUND DRESSING

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