K-number	K821394
Device name	SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER
Applicant	Kleen Test Products
Product code	MMK
Device class	Class II
Decision date	Jun 3, 1982
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER

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