ACUFEX PROBES— 510(k) K800274

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K800274 for ACUFEX PROBES, Substantially Equivalent on 1980-02-19. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HXB
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1980-02-07
Decision date: 1980-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K952535 — ACUFEX ENDOBUTTON TAPE1996-02-08
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Data sourced from openFDA. This site is unofficial and independent of the FDA.