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510(k) K202128

Allmed Surgical Face Masks (Ear loops) by Allmed Medical Products Co., Ltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2021
Date Received
July 31, 2020
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 Allmed Medical Products Co., Ltd.

  • K221570 — Antibacterial bandage (September 29, 2023)
  • K202411 — Surgical Mask (March 10, 2021)
  • K202409 — Surgical Mask (March 9, 2021)

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