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510(k) K972918

RAPID FIRE HAIR IMPLANTER CAROUSEL by Apex Medical Products, LLC — Product Code GAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1997
Date Received
August 7, 1997
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

Other clearances for product code GAH

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  • K000932 — ARACHNOPHLEBECTOMY NEEDLE (May 17, 2000)
  • K970306 — MARKMAN TEMPLATE SYSTEM (November 20, 1997)
  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • K952737 — CALVITRON HAIR TRANSPLANT SYSTEM (October 3, 1995)
  • K770970 — HAIR TRANSPLANT PUNCH, MULTIPLH (October 27, 1977)