Pre-Pack Tens

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813286 ↗

FDA Product Code

GDY

Device Class

Class I

Regulation

21 CFR Part 878.4450

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Venous Cannula Tray

  Class I

  FDA 510(k) K813284 Active Cleared 29 Dec 1981

• One Step Prep Kit

  Not classified

  FDA 510(k) K811089 Active Cleared 8 May 1981

• Subclavian Insertion Kit

  Class II

  FDA 510(k) K823527 Active Cleared 31 Mar 1983

• Mika Skin Scrub Tray Pre Operative W/Gel

  Class I

  FDA 510(k) K811087 Active Cleared 1 May 1981

• Dressing Tray Mercy Hospital

  Not classified

  FDA 510(k) K811088 Active Cleared 8 May 1981

• Minor Dressing Tray

  Not classified

  FDA 510(k) K811091 Active Cleared 8 May 1981

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