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510(k) K800315

DUAL MPC CHARGER by Black & Decker(Tm) — Product Code KIJ

K800315 is an FDA 510(k) premarket notification submitted by Black & Decker(Tm) for the device "DUAL MPC CHARGER". The FDA issued a decision of Substantially Equivalent on March 19, 1980. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Black & Decker(Tm) has at least 10 other 510(k) clearances on record.

Clearance Details

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

Other clearances for product code KIJ

  • K163308 — SMARTO (December 27, 2016)
  • K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT (November 6, 2012)
  • K101563 — SMARTO (December 17, 2010)
  • 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)

FDA data resources