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510(k) K904969

HOOD, OPERATING, SURGICAL by Chicago Assoc. For Retarded Citizens — Product Code FXY

K904969 is an FDA 510(k) premarket notification submitted by Chicago Assoc. For Retarded Citizens for the device "HOOD, OPERATING, SURGICAL". The FDA issued a decision of Substantially Equivalent on December 12, 1990. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1990
Date Received
November 5, 1990
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

Other clearances for product code FXY

  • K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (October 17, 2023)
  • K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgi (March 21, 2020)
  • K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (June 26, 2014)
  • 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)

FDA data resources