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510(k) K911865

NORTEC CONNECTING TUBE SET by North American Sterilization & Packaging Co. — Product Code GAZ

K911865 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NORTEC CONNECTING TUBE SET". The FDA issued a decision of Substantially Equivalent on November 1, 1991. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1991
Date Received
April 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K910691 — NORTEC URETERAL STENT (August 15, 1991)
  • K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES (December 18, 1990)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K945978 — TUBING, NONINVASIVE (January 11, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K861757 — 5 IN 1 CONNECTOR (June 6, 1986)

FDA data resources