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510(k) K891056

SURGICAL CONE MASK by Dispomed, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1989
Date Received
February 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Dispomed, Inc.

  • K892748 — PATIENT EXAM GLOVES (MFG. AMMATEX) (August 10, 1989)
  • K891054 — NON-STERILE GAUZE SPONGE (May 1, 1989)
  • K891051 — SURGICAL FACE MASK-EAR LOOP (April 12, 1989)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K891058 — DENTAL GOWN (April 12, 1989)
  • K891052 — SPLASH GUARD GOGGLE (April 12, 1989)

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  • K252650 — Disposable Medical Face Mask (January 5, 2026)
  • K243342 — KP Protective Face Mask (December 22, 2025)
  • K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (December 11, 2025)
  • K252964 — PRIMED Surgical and Procedure Masks (November 4, 2025)
  • K251902 — Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with S (September 17, 2025)
  • K250082 — Procedure mask/Surgical mask/Face mask (June 18, 2025)
  • K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); (May 30, 2025)