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510(k) K841627

MALLET by Plastafil, Inc. — Product Code HWA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
April 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Plastafil, Inc.

  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K841620 — FRONT RADIUS CUTTER (September 20, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841629 — DRILL BIT (August 27, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)

Other clearances for product code HWA

  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 1994)
  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K770205 — CEMENT CHISELS (February 8, 1977)