MICRO-AIRE STERNUM SAW REPLACEMENT BLADES— 510(k) K850483

Name: FDA 510(k) clearance K850483
Creator: U.S. Food and Drug Administration
Published: 1985-03-01

Substantially Equivalent

Micro-Aire Surgical Instruments, Inc.

FDA 510(k) clearance K850483 for MICRO-AIRE STERNUM SAW REPLACEMENT BLADES, Substantially Equivalent on 1985-03-01. Applicant: Micro-Aire Surgical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Micro-Aire Surgical Instruments, Inc.
Product code: Code DWH
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1985-02-07
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Fernando, CA, US

Download summary PDF View on FDA.gov ↗

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K830189 — CARDIOVASCULAR SAW BLADES1983-03-24

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K903713 — OSTEOTOME MODEL NUMBERS 2500-228 & 2500-2291990-09-14
K903664 — MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL1990-09-13

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