Device Classification Name |
More FDA Info for this Device |
510(K) Number |
K220475 |
Device Name |
Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) |
Applicant |
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No. 278, Hangkong Road
Tianjin Pilot Free Trade Zone(Air Port Industrial Park)
Tianjian 300308 CN
Other 510(k) Applications for this Company
|
Contact |
Yuan Ying
Other 510(k) Applications for this Contact |
Regulation Number |
More FDA Info for this Regulation Number |
Classification Product Code |
QRL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
02/18/2022 |
Decision Date |
07/06/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
SU - General & Plastic Surgery |
Review Advisory Committee |
SU - General & Plastic Surgery |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|