Name: Predicase
Price: 199 USD

K-number	K981614
Device name	NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL
Applicant	Aaron Medical Industries
Product code	GEI
Device class	Class II
Decision date	Jul 17, 1998
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL

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