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510(k) K820351

CAST CUTTER/CAST SAW/INSTRUMENT by Black & Decker(Tm) — Product Code LGH

K820351 is an FDA 510(k) premarket notification submitted by Black & Decker(Tm) for the device "CAST CUTTER/CAST SAW/INSTRUMENT". The FDA issued a decision of Substantially Equivalent on March 2, 1982. The device falls under product code LGH (Instrument, Cast Removal, Ac-Powered), a Class I device regulated under 21 CFR 888.5960. Black & Decker(Tm) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1982
Date Received
February 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cast Removal, Ac-Powered
Device Class
Class I
Regulation Number
888.5960
Review Panel
OR
Submission Type

Other clearances by Black & Decker(Tm)

  • K812437 — 150 DRIVER REAMER (November 2, 1981)
  • K812438 — SAGITTAL SAW (November 2, 1981)
  • K812436 — 450/800 DRILL (November 2, 1981)
  • K812440 — POWER PACK (November 2, 1981)
  • K812439 — DUAL MPC CHARGER (November 2, 1981)
  • K800315 — DUAL MPC CHARGER (March 19, 1980)
  • K800314 — POWER PACK (March 19, 1980)
  • K800312 — 150 DRIVER/REAMER (February 22, 1980)
  • K800313 — SAGITTAL SAW (February 22, 1980)
  • K800311 — 450 DRILL/800 DRILL (February 22, 1980)

Other clearances for product code LGH

  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K901677 — CARAPACE PORTABLE CAST SAW, SWISS-EX CAST CUTTER (April 23, 1990)
  • K893380 — QCR SYSTEM I AND QCR SYSTEM II (November 16, 1989)
  • K895861 — DELTA-TECH(TM) CAST REMOVAL SYSTEM (October 19, 1989)
  • K873723 — PLASTER VACUUM, 230V MODEL NO. 4183-161 (December 10, 1987)
  • K873721 — PLASTER VACUUM, 115V MODEL NO. 4183-160 (December 7, 1987)
  • K873719 — CAST CUTTER, 115V MODEL NO. 4183-106 (October 2, 1987)
  • K873720 — CAST CUTTER, 230V MODEL NO. 4183-107 (October 2, 1987)

FDA data resources