SCALPEL— 510(k) K780998

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K780998 for SCALPEL, Substantially Equivalent on 1978-07-27. Applicant: Isolab, Inc.. Device class: 1.

Clearance details

Applicant: Isolab, Inc.
Product code: Code GDX
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1978-06-14
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.