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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Surgical, General & Plastic Surgery
510(k) Number K972918
Device Name RAPID FIRE HAIR IMPLANTER CAROUSEL
Applicant
APEX MEDICAL PRODUCTS, LLC.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN R ESTRIN
Correspondent
APEX MEDICAL PRODUCTS, LLC.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN R ESTRIN
Regulation Number878.4800
Classification Product Code
GAH  
Date Received08/07/1997
Decision Date 10/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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