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510(k) K940903

TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES by Medical Insights, Inc. — Product Code KBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1994
Date Received
February 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dissector, Tonsil
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Medical Insights, Inc.

  • K940904 — KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD (April 14, 1994)
  • K940901 — NON-WOVEN SPONGE (March 31, 1994)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)