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510(k) K933742

TOP GUN by Bio-Medical Devices, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
August 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Bio-Medical Devices, Inc.

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  • 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)

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