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510(k) K874961

BONE CUTTING INSTRUMENTS & ACCESSORIES by Solway, Inc. — Product Code GDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saw, Manual And Accessories
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)

Other clearances for product code GDR

  • K851787 — 27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATT (June 20, 1985)