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510(k) K901511

CHISEL, BONE, SURGICAL by Mumtaz I. Malik — Product Code LXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1990
Date Received
March 29, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Mumtaz I. Malik

  • K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (September 28, 1990)
  • K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (September 28, 1990)
  • K901521 — OSTEOTOMES OF VARIOUS TYPES (September 28, 1990)
  • K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY (July 14, 1989)
  • K890071 — STERILE LACERATION TRAY (January 24, 1989)
  • K884195 — GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (October 24, 1988)

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