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510(k) K820344

ROWE SHOULDER INSTR. FOR BANKHART REPAIR by New England Surgical Instrument Corp. — Product Code HTD

Clearance Details

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

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by New England Surgical Instrument Corp.

  • K895331 — ELECTROSURGICAL ELECTRODE (September 15, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K883963 — RANEY AND LEROY-RANEY SCALP CLIP (October 7, 1988)
  • K883396 — HANDSWITCHING MONOPOLAR PENCIL (September 13, 1988)
  • K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 (April 19, 1988)
  • K880859 — SURGICAL BURS (March 21, 1988)
  • K872271 — VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS (June 26, 1987)
  • K872209 — ARTHROPLASTY MALLET (June 23, 1987)
  • K864770 — SUCTION TUBE (February 24, 1987)
  • K864775 — CHISEL (OSTEOTOME, GOUGE, ETC.) (February 12, 1987)

Other clearances for product code HTD

  • K051281 — THE NEEDLE CATCHER (September 8, 2005)
  • K974595 — CUSHING BAYONET, INSULATED BIPOLAR FORCEP (June 24, 1998)
  • K974594 — SEMKIN BIPOLAR FORCEP (June 24, 1998)
  • K974593 — SEMKIN INSULATED BIPOLAR FORCEP (June 24, 1998)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 1991)
  • K911180 — CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (March 29, 1991)
  • K895212 — TIK EXTRAKTOR (September 27, 1989)
  • K890373 — HEMORRHOIDAL FORCEPS (February 3, 1989)
  • K890369 — GALL STONE FORCEPS (February 3, 1989)
  • K890258 — BONE CUTTING FORCEPS, SINGLE-ACTION (January 27, 1989)