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510(k) K994191

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T by Nmt Medical, Inc. — Product Code HCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2000
Date Received
December 13, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Aneurysm Clip
Device Class
Class II
Regulation Number
882.4175
Review Panel
NE
Submission Type

Other clearances by Nmt Medical, Inc.

  • K034025 — NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC (March 26, 2004)

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  • K984109 — AESCULAP AXIAL CLIP APPLIER (February 12, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K954658 — PERNECZKY CLIP APPLIER/REMOVER (October 8, 1996)
  • K940970 — YASARGIL, CASPAR, VARIO CLIP APPLIERS (January 24, 1995)
  • K902544 — SUNDT AVM MICRO CLIP (September 20, 1990)