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510(k) K842823

CHERMEL OSTEOTOMES by Cher Mel Corp. — Product Code GFI

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
Osteotome, Manual
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)
  • K842822 — CHERMEL BONE GOUGES (August 2, 1984)
  • K842824 — CHERMEL BONE CHISELS (August 2, 1984)

Other clearances for product code GFI

  • K933181 — VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (November 2, 1993)
  • K932534 — ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (August 19, 1993)
  • K920001 — HEMOLAB SILIMAT REAGENT (September 25, 1992)
  • K891887 — OSTEOTOMES, VARIOUS TYPES (April 12, 1989)
  • K852541 — STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (July 11, 1985)