510(k) K952737

CALVITRON HAIR TRANSPLANT SYSTEM by Medicamat S.A. — Product Code GAH

K952737 is an FDA 510(k) premarket notification submitted by Medicamat S.A. for the device "CALVITRON HAIR TRANSPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 3, 1995. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Medicamat S.A. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1995
Date Received
June 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type