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510(k) K200493

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover by Stryker Corporation — Product Code FXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2020
Date Received
February 28, 2020
Clearance Type
Traditional
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

  • K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (October 17, 2023)
  • K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (June 26, 2014)
  • K904969 — HOOD, OPERATING, SURGICAL (December 12, 1990)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)
  • 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)