SAFE.N.SURE— 510(k) K852620

Substantially Equivalent

Ashai Co. , Ltd.

FDA 510(k) clearance K852620 for SAFE.N.SURE, Substantially Equivalent on 1985-10-31. Applicant: Ashai Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Ashai Co. , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1985-06-20
Decision date: 1985-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Ashai Co. , Ltd.

K870428 — AEROSOL ONE, NEBULIZER PUMP1987-05-15
K852622 — AEROSOL ONE1986-04-24
K852627 — MAXI-NEB1985-09-26
K852618 — OXY-DIAL1985-09-18
K852623 — OXY-ONE1985-09-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.