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510(k) K891037

WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE by Zinnanti Surgical Instruments, Inc. — Product Code HFD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1989
Date Received
February 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Endometrial
Device Class
Class II
Regulation Number
884.1185
Review Panel
OB
Submission Type

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  • K925957 — SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K925960 — FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE (June 7, 1994)
  • K926021 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE (April 7, 1994)
  • K925958 — SCISSOR FOR LAPAROSCOPIC SURGERY GU USE (March 24, 1994)
  • K926181 — ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY (December 17, 1993)
  • K926016 — NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE (November 12, 1993)

Other clearances for product code HFD

  • K890376 — VAGINAL SPECULUM (February 27, 1989)
  • K810558 — SKIN SCRUB TRAY (March 17, 1981)