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510(k) K772376

NEIVERT OSTEOTOME by Edward Weck, Inc. — Product Code KDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1978
Date Received
December 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel (Osteotome)
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type

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  • K871110 — CORONARY ARTERY BYPASS GRAFT (CABG) MARKER (August 27, 1987)
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  • K891471 — SIL-MED WASTE FLUID DUMP BAG (August 15, 1989)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)