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510(k) K904276

DISPOSABLE BEARD COVER by Anago, Inc. — Product Code FXY

K904276 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "DISPOSABLE BEARD COVER". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. Anago, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
September 19, 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 by Anago, Inc.

  • K925659 — U.C.E.Z. LENS CLEANER KIT (September 17, 1993)
  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K920615 — ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (March 20, 1993)
  • K915415 — GUARDALL SHIELD (October 15, 1992)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)

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)
  • K904969 — HOOD, OPERATING, SURGICAL (December 12, 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