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510(k) K943583

KERRISON RONGEURS by Enterprise Medical Corp. — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1995
Date Received
July 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type

Other clearances by Enterprise Medical Corp.

  • K942431 — LAPOROSCOPIC SCISSORS (October 11, 1995)
  • K941816 — EMC FLEXIBLE BIOPSY FORCEPS (July 13, 1994)

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  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
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  • K180949 — Steribite (November 8, 2018)
  • K161744 — Symmetry Sharp Kerrison Rongeur (September 7, 2016)