MINIJECT— 510(k) K991888

Substantially Equivalent

Spartan Ultrasonics, Inc.

FDA 510(k) clearance K991888 for MINIJECT, Substantially Equivalent on 1999-08-25. Applicant: Spartan Ultrasonics, Inc.. Device class: 2.

Clearance details

Applicant: Spartan Ultrasonics, Inc.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 1999-06-02
Decision date: 1999-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fenton, MO, US

Download summary PDF View on FDA.gov ↗

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