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510(k) K800311

450 DRILL/800 DRILL by Black & Decker(Tm) — Product Code KIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1980
Date Received
February 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Black & Decker(Tm)

  • K820351 — CAST CUTTER/CAST SAW/INSTRUMENT (March 2, 1982)
  • K812437 — 150 DRIVER REAMER (November 2, 1981)
  • K812440 — POWER PACK (November 2, 1981)
  • K812439 — DUAL MPC CHARGER (November 2, 1981)
  • K812436 — 450/800 DRILL (November 2, 1981)
  • K812438 — SAGITTAL SAW (November 2, 1981)
  • K800315 — DUAL MPC CHARGER (March 19, 1980)
  • K800314 — POWER PACK (March 19, 1980)
  • K800313 — SAGITTAL SAW (February 22, 1980)
  • K800312 — 150 DRIVER/REAMER (February 22, 1980)

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  • K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (September 4, 1997)
  • K970378 — STRYKER 2115 REPLACEMENT BATTERY (2115) (April 30, 1997)
  • K960711 — ACUMED BONE GRAFT SYSTEM (May 7, 1996)
  • K951450 — SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY (May 17, 1995)
  • K944488 — S & S ORTHOPEDIC WIRE DRIVER 701 (March 2, 1995)
  • K941285 — ARTHREX GRAFT HARVESTING KIT (November 14, 1994)
  • K933101 — THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (November 7, 1994)