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510(k) K842822

CHERMEL BONE GOUGES by Cher Mel Corp. — Product Code GDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1984
Date Received
July 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gouge, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Cher Mel Corp.

  • K863040 — DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS (October 31, 1986)
  • K851516 — CHERMEL SCALP VEIN SET (August 23, 1985)
  • K842203 — LITTMAN TYPE SH-6010, NURSE TYPE (June 6, 1985)
  • K843324 — SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH (June 6, 1985)
  • K842823 — CHERMEL OSTEOTOMES (August 2, 1984)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)

Other clearances for product code GDH

  • K903419 — MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE (August 9, 1990)
  • K900487 — MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE (February 9, 1990)
  • K891901 — GOUGES, ALEXANDER, BISHOP, LUCAS (April 12, 1989)
  • K874879 — AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (December 17, 1987)
  • K760850 — PARKES HUMP GAUGE STRAIGHT 7 (18 CM) (November 3, 1976)