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FDA 510(k) Application Details - K192627
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K192627
Device Name
Laser, Comb, Hair
Applicant
Shang Fa Biotechnology Co.
B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist.,
New Taipei City 23677 TW
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Contact
Chung Ju Zhi
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2019
Decision Date
12/13/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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