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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 K952737
Device Name CALVITRON HAIR TRANSPLANT SYSTEM
Applicant
MEDICAMAT S.A.
1776 K STREET, N.W.
WASHINGTON,  DC  20006
Applicant Contact ANDREW S KRULWICH
Correspondent
MEDICAMAT S.A.
1776 K STREET, N.W.
WASHINGTON,  DC  20006
Correspondent Contact ANDREW S KRULWICH
Regulation Number878.4800
Classification Product Code
GAH  
Date Received06/15/1995
Decision Date 10/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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