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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 K172982
Device Name SuperGrow 272, Ultimate 272
Applicant
Super Grow Lasers
1903 Commonwealth St. #16
Houston,  TX  77006
Applicant Contact Jeff Stanifer
Correspondent
Acknowledge Regulatory Strategies
2834 Hawthorn St.
San Diego,  CA  92104
Correspondent Contact Allison Komiyama
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/27/2017
Decision Date 12/19/2017
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
Predetermined Change
Control Plan Authorized		 No
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