GENTLEHALER(R)— 510(k) K892117

Substantially Equivalent

Schering Research

FDA 510(k) clearance K892117 for GENTLEHALER(R), Substantially Equivalent on 1989-06-23. Applicant: Schering Research. Device class: 1.

Clearance details

Applicant: Schering Research
Product code: Code CCQ
Device class: Class 1
Regulation: 21 CFR 868.5640
Advisory panel: Anesthesiology
Date received: 1989-03-31
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kenilworth, NJ, US

Download summary PDF View on FDA.gov ↗

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