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510(k) K140588

FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS by Stryker Corporation — Product Code FXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2014
Date Received
March 7, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code FXY

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  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)
  • K770261 — HOOD, CLARION SURGEONS (March 1, 1977)
  • K770257 — HOOD & BEARD COVER, CLARION SURGEON'S (February 25, 1977)
  • K761070 — P.S.M. SURGICAL HOOD (December 30, 1976)