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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, comb, hair
510(k) Number K192627
Device Name Laser Hair Growth Cap
Applicant
Shang Fa Biotechnology Co.
B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist.,
New Taipei City,  TW 23677
Applicant Contact Chung Ju Zhi
Correspondent
Shang Fa Biotechnology Co.
B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist.,
New Taipei City,  TW 23677
Correspondent Contact Chung Ju Zhi
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/23/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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