MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE— 510(k) K880740

Name: FDA 510(k) clearance K880740
Creator: U.S. Food and Drug Administration
Published: 1988-03-22

Substantially Equivalent

Spectramed, Inc.

FDA 510(k) clearance K880740 for MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE, Substantially Equivalent on 1988-03-22. Applicant: Spectramed, Inc.. Device class: 2.

Clearance details

Applicant: Spectramed, Inc.
Product code: Code DQF
Device class: Class 2
Regulation: 21 CFR 870.1670
Advisory panel: Cardiovascular
Date received: 1988-02-24
Decision date: 1988-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, CA, 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.