Name: Predicase
Price: 199 USD

K-number	K951835
Device name	MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE
Applicant	Life Technologies, Inc.
Product code	MFD
Device class	Class II
Decision date	Aug 11, 1995
Decision	Substantially Equivalent
Regulation	884.5250

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE

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