Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Mask, Surgical
510(k) Number K220876
Device Name AOK 95A Medical Mask (20200049)
Applicant
Aok Tooling Limited
Flat 2009, 20/F, Kowloon Plz., #485, Castle Peak Rd.
Cheung Sha Wan, Kowloon,  CN 518122
Applicant Contact Francis Nithyananthan
Correspondent
Aok Tooling Limited C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number878.4040
Classification Product Code
FXX  
Date Received03/25/2022
Decision Date 07/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-