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510(k) K040485

MAXAIR SURGICAL HELMET SYSTEM by Bio-Medical Devices, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2004
Date Received
February 25, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Bio-Medical Devices, Inc.

  • K981888 — SMOKE-EVAC (October 15, 1998)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (January 24, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (January 24, 1996)
  • K955150 — MAXI-FLOW (January 23, 1996)
  • K940156 — THE REEL THING (June 7, 1994)
  • K933742 — TOP GUN (April 7, 1994)

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