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510(k) K841617

STROVER HOOK by Plastafil, Inc. — Product Code HCF

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
Instrument, Ligature Passing And Knot Tying
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K841627 — MALLET (August 27, 1984)
  • K841626 — PUNCH (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841629 — DRILL BIT (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841623 — SLOTTED SOFT-TISSUE INSTRUMENT (July 11, 1984)

Other clearances for product code HCF

  • K150882 — Edwards Suture Fastening System (June 16, 2015)
  • K931379 — MICROVASIVE INSURG LAPTIE SUTURE LIGATOR (July 13, 1993)
  • K851452 — VALTRAC PURSESTING DEVICE (June 12, 1985)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)