Name: Predicase
Price: 199 USD

K-number	K983183
Device name	GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
Applicant	Bien Air USA, Inc.
Product code	EFB
Device class	Class I
Decision date	Dec 10, 1998
Decision	Substantially Equivalent
Regulation	872.4200

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View the full FDA submission: accessdata.fda.gov

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GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P

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