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510(k) K970306

MARKMAN TEMPLATE SYSTEM by Barry Markman, M.D. — Product Code GAH

K970306 is an FDA 510(k) premarket notification submitted by Barry Markman, M.D. for the device "MARKMAN TEMPLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 20, 1997. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
January 27, 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)
  • K972918 — RAPID FIRE HAIR IMPLANTER CAROUSEL (October 27, 1997)
  • K972521 — NAVIGATOR (STYLET) 2006 (October 1, 1997)
  • K952737 — CALVITRON HAIR TRANSPLANT SYSTEM (October 3, 1995)
  • K770970 — HAIR TRANSPLANT PUNCH, MULTIPLH (October 27, 1977)

FDA data resources