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510(k) K910691

NORTEC URETERAL STENT by North American Sterilization & Packaging Co. — Product Code FAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1991
Date Received
February 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by North American Sterilization & Packaging Co.

  • K964231 — NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (March 10, 1997)
  • K963753 — NASP TRANSPARENT DRESSING (November 29, 1996)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (December 3, 1993)
  • K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION (December 3, 1993)
  • K925161 — NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO (July 21, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)
  • K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES (December 18, 1990)

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