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510(k) K895212

TIK EXTRAKTOR by Instruments of Sweden, Inc. — Product Code HTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1989
Date Received
August 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K974595 — CUSHING BAYONET, INSULATED BIPOLAR FORCEP (June 24, 1998)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 1991)
  • K911180 — CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS (March 29, 1991)
  • K890369 — GALL STONE FORCEPS (February 3, 1989)
  • K890373 — HEMORRHOIDAL FORCEPS (February 3, 1989)
  • K890263 — CILIA FORCEPS (January 27, 1989)
  • K890234 — SUTURE CLIP REMOVER (January 27, 1989)