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510(k) K834364

CRYSTALLINE BONE SCREW ENDO-OSSEOUS by C.B.S. Biotechnics, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1984
Date Received
October 27, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by C.B.S. Biotechnics, Inc.

  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K834363 — ENDIX RADICULAR BIOCERAMIC PIN (February 27, 1984)
  • K834366 — SURGICAL INSTRUMENTS & ACCESSORIES (February 27, 1984)

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