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510(k) K900665

DRESSING CHANGE KIT by Healthdyne Cardiovascular, Inc. — Product Code FXX

Clearance Details

Decision
SN ()
Decision Date
May 14, 1990
Date Received
February 13, 1990
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 Healthdyne Cardiovascular, Inc.

  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 1990)
  • K901382 — ISOFLO(TM) HIGH PRESSURE INJECTION LINES (July 19, 1990)
  • K901084 — ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. (June 1, 1990)
  • K895763 — ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING (December 22, 1989)

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  • K252830 — Disposable Surgical Face Mask (3P00B, C2900) (January 12, 2026)
  • 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)