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510(k) K841626

PUNCH by Plastafil, Inc. — Product Code HXG

K841626 is an FDA 510(k) premarket notification submitted by Plastafil, Inc. for the device "PUNCH". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code HXG (Tamp), a Class I device regulated under 21 CFR 888.4540. Plastafil, Inc. has at least 10 other 510(k) clearances on record.

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
Tamp
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)
  • K841621 — BACK RADIUS CUTTER (September 20, 1984)
  • K841625 — HOOK (August 27, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K841624 — PROBE (August 27, 1984)
  • K841629 — DRILL BIT (August 27, 1984)
  • K841627 — MALLET (August 27, 1984)
  • K841628 — WIRE (July 23, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)

FDA data resources