CURVTEK TSR SYSTEM— 510(k) K972860

Substantially Equivalent

Biolectron, Inc.

FDA 510(k) clearance K972860 for CURVTEK TSR SYSTEM, Substantially Equivalent on 1997-10-31. Applicant: Biolectron, Inc.. Device class: 1.

Clearance details

Applicant: Biolectron, Inc.
Product code: Code HSZ
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1997-08-04
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, 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.