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510(k) K812105

ANOGO DISPOSABLE SHOE COVER by Anago, Inc. — Product Code BWP

K812105 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "ANOGO DISPOSABLE SHOE COVER". The FDA issued a decision of Substantially Equivalent on September 11, 1981. The device falls under product code BWP (Shoe And Shoe Cover, Conductive), a Class I 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
September 11, 1981
Date Received
July 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoe And Shoe Cover, Conductive
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
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)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (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 BWP

  • K880384 — KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (June 23, 1988)
  • K831952 — SURGICAL APPAREL SHOE COVERS (July 12, 1983)

FDA data resources