AIRPREP SYSTEM - MODEL 9001— 510(k) K974488

Substantially Equivalent

Asi Medical, Inc.

FDA 510(k) clearance K974488 for AIRPREP SYSTEM - MODEL 9001, Substantially Equivalent on 1998-05-26. Applicant: Asi Medical, Inc.. Device class: 2.

Clearance details

Applicant: Asi Medical, Inc.
Product code: Code KOJ
Device class: Class 2
Regulation: 21 CFR 872.6080
Advisory panel: Dental
Date received: 1997-11-26
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

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