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510(k) K931155

STAPLE, FIXATION BONE; SCREW FIXATION BONE by Roseburg SA — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1994
Date Received
March 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Roseburg SA

  • K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES (March 9, 1989)
  • K885275 — ASSENAT-BLESCHET SUNGLASSES (January 24, 1989)
  • K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (August 26, 1988)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR (November 17, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K871689 — SPECTACLE FRAME - LORRAINE (May 29, 1987)
  • K871688 — SPECTACLE FRAME - DANIELLE (May 29, 1987)
  • K870654 — EFER ARTHROSCOPE (May 14, 1987)
  • K864436 — STAVIP 3000 (March 16, 1987)

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