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510(k) K841621

BACK RADIUS CUTTER by Plastafil, Inc. — Product Code HTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
April 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Plastafil, Inc.

  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841627 — MALLET (August 27, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841629 — DRILL BIT (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)

Other clearances for product code HTX

  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K780397 — ORTHOPEDIC FORCEPS (March 22, 1978)
  • K760325 — SURGICAL INSTRUMENTS, ORTHOPEDIC (August 3, 1976)