Home / 510(k) Clearances / K864775

510(k) K864775

CHISEL (OSTEOTOME, GOUGE, ETC.) by New England Surgical Instrument Corp. — Product Code EMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1987
Date Received
December 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chisel, Osteotome, Surgical
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
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)
  • K864771 — CHUCK HANDLE (February 4, 1987)

Other clearances for product code EMM

  • K963897 — STERI-OSS SINUS AUGMENTATION KIT (November 6, 1996)
  • K851714 — 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS (June 11, 1985)
  • K760959 — SURGICAL CHISEL (November 15, 1976)