SYNCHRONER TM (PROPOSED TRADENAME)— 510(k) K853350

Name: FDA 510(k) clearance K853350
Creator: U.S. Food and Drug Administration
Published: 1985-08-29

Substantially Equivalent

Fisons Corp.

FDA 510(k) clearance K853350 for SYNCHRONER TM (PROPOSED TRADENAME), Substantially Equivalent on 1985-08-29. Applicant: Fisons Corp.. Device class: 1.

Clearance details

Applicant: Fisons Corp.
Product code: Code CCQ
Device class: Class 1
Regulation: 21 CFR 868.5640
Advisory panel: Anesthesiology
Date received: 1985-08-12
Decision date: 1985-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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