Sterile Saline Solution

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843797 ↗

FDA Product Code

BSY

Device Class

Class I

Regulation

21 CFR Part 868.6810

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bandage

  Class I

  FDA 510(k) K761093 Active Cleared 6 Jan 1977

• Charter Wetting Solution for Hard Contact Lenses

  Unclassified

  FDA 510(k) K862952 Active Cleared 25 Sep 1986

• Charter Laboratories Inc. Lens Lubricant

  Unclassified

  FDA 510(k) K863974 Active Cleared 10 Nov 1986

• Sterile Water

  Not classified

  FDA 510(k) K843796 Active Cleared 10 Dec 1984

• Charter Hard Contact Lens Cleaning Solution

  Unclassified

  FDA 510(k) K865111 Active Cleared 20 Jan 1987

• Non-Preserved Saline Solution

  Class II

  FDA PMA P850025 Active Approved 9 Sep 1986

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