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510(k) K842824

CHERMEL BONE CHISELS by Cher Mel Corp. — Product Code KDG

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
Chisel (Osteotome)
Device Class
Class I
Regulation Number
878.4820
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)
  • K842822 — CHERMEL BONE GOUGES (August 2, 1984)

Other clearances for product code KDG

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 1995)
  • K952200 — OMNI-JUG (June 29, 1995)
  • K894785 — SURGICAL CHISEL/OSTEOTOME (August 18, 1989)
  • K891471 — SIL-MED WASTE FLUID DUMP BAG (August 15, 1989)
  • K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS (August 21, 1987)
  • K872092 — OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (June 23, 1987)
  • K772373 — ANDERSON-NEIVERT OSTEOTOME (March 9, 1978)
  • K772376 — NEIVERT OSTEOTOME (March 9, 1978)
  • K772374 — SILVER OSTEOTOME (March 9, 1978)
  • K780135 — CEMENT EXTRACTION INSTRUMENT SET (January 31, 1978)