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510(k) K812438

SAGITTAL SAW by Black & Decker(Tm) — Product Code GEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
August 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Ac-Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
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)
  • K800314 — POWER PACK (March 19, 1980)
  • K800315 — DUAL MPC CHARGER (March 19, 1980)
  • K800313 — SAGITTAL SAW (February 22, 1980)
  • K800311 — 450 DRILL/800 DRILL (February 22, 1980)
  • K800312 — 150 DRIVER/REAMER (February 22, 1980)

Other clearances for product code GEY

  • K050519 — ADVANCED TURBO DRIVE SYSTEM (May 17, 2005)
  • K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (March 28, 2002)
  • K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (November 14, 2001)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K971941 — AQUA SPRAY (August 14, 1997)
  • K971782 — BONE AND MARROW COLLECTION SYSTEM KIT (July 29, 1997)
  • K971268 — BONE & MARROW CLLECTION SYSTEM (July 3, 1997)
  • K964252 — ORTHOCHUCK (May 27, 1997)
  • K970530 — ANSPACH LUBRICATING SYSTEM II (May 5, 1997)
  • K964073 — BME BONE DRILL BITS (November 14, 1996)