MAXAIR SURGICAL HELMET SYSTEM— 510(k) K040485

Substantially Equivalent

Bio-Medical Devices, Inc.

FDA 510(k) clearance K040485 for MAXAIR SURGICAL HELMET SYSTEM, Substantially Equivalent on 2004-10-18. Applicant: Bio-Medical Devices, Inc..

Clearance details

Applicant: Bio-Medical Devices, Inc.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2004-02-25
Decision date: 2004-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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