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510(k) K912651

AIRSAFE MINIVAC SMOKE FILTRATION SYSTEM by Stackhouse Assoc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1991
Date Received
June 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

Other clearances by Stackhouse Assoc.

  • K910515 — FREEDOM MARK III SURGICAL HELMET SYSTEM (May 6, 1991)
  • K874512 — MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM (January 27, 1988)
  • K872935 — ANTI-INFECTION SHIELD (November 9, 1987)
  • K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (May 23, 1979)

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