Mask, Isolation

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780609 ↗

FDA Product Code

FXX

Device Class

Class II

Regulation

21 CFR Part 878.4040

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Microscope Slides

  Class I

  FDA 510(k) K862112 Active Cleared 13 Jun 1986

• Sterile IV Set 4 Sizes

  Class II

  FDA 510(k) K832329 Active Cleared 24 Aug 1983

• Sterile, Foley Catheters W/Ptfe Coat

  Class II

  FDA 510(k) K841678 Active Cleared 19 Jul 1984

• Instrument Lubricant

  Not classified

  FDA 510(k) K780610 Active Cleared 31 May 1978

• Abco Mercurial Sphygmomanometer

  Class II

  FDA 510(k) K800236 Active Cleared 22 Feb 1980

• Abco Midstream Urine Collection Set

  Class I

  FDA 510(k) K800233 Active Cleared 26 Feb 1980

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