FDA 510(k) Application Details - K210856

Device Classification Name Mask, Surgical

  More FDA Info for this Device
510(K) Number K210856
Device Name Mask, Surgical
Applicant Chuzhou Daddy's Choice Science and Technology Co., Ltd.
Middle of Nanjing Road, Langya District
Chuzhou 239000 CN
Other 510(k) Applications for this Company
Contact Amie Yang
Other 510(k) Applications for this Contact
Regulation Number 878.4040

  More FDA Info for this Regulation Number
Classification Product Code FXX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/23/2021
Decision Date 07/28/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact