K-number	K862365
Device name	NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
Applicant	Swemed Laboratories, Inc.
Product code	HIO
Device class	Class I
Decision date	Jul 7, 1986
Decision	Substantially Equivalent
Regulation	884.1550

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NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE

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