ACUFLEX DISPOSABLE KNIVES— 510(k) K933921

Name: FDA 510(k) clearance K933921
Creator: U.S. Food and Drug Administration
Published: 1994-01-26

Substantially Equivalent

Acufex Microsurgical, Inc.

FDA 510(k) clearance K933921 for ACUFLEX DISPOSABLE KNIVES, Substantially Equivalent on 1994-01-26. Applicant: Acufex Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTS
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1993-08-10
Decision date: 1994-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K873714 — BANANA KNIFE, DISPOSABLE #TM-16121987-11-02

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K952535 — ACUFEX ENDOBUTTON TAPE1996-02-08
K953276 — ACUFEX TAG DELIVERY SYSTEM1995-10-05

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