510(k) K841741

SINGLE HAIR TRANSPLANT GRAFT by Paris Products, Inc. — Product Code FZT

K841741 is an FDA 510(k) premarket notification submitted by Paris Products, Inc. for the device "SINGLE HAIR TRANSPLANT GRAFT". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
April 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cutter, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type