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510(k) K832880

TRACHEOSTOMY CARE TRAYS by Packaging Technologies, Inc. — Product Code JOL

K832880 is an FDA 510(k) premarket notification submitted by Packaging Technologies, Inc. for the device "TRACHEOSTOMY CARE TRAYS". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code JOL (Catheter And Tip, Suction), a Class II device regulated under 21 CFR 880.6740. Packaging Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
August 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Packaging Technologies, Inc.

  • K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
  • K863326 — BONE MARROW TRAY (September 16, 1986)
  • K861041 — ENHANCE (May 30, 1986)
  • K850544 — SHAVE PREP TRAY (March 12, 1985)
  • K850438 — RENAL BIOPSY TRAY (February 26, 1985)
  • K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
  • K844611 — SINGLE BASIN SET (December 19, 1984)
  • K844614 — IV START KIT (December 19, 1984)
  • K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
  • K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)

Other clearances for product code JOL

  • K051370 — STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F (August 12, 2005)
  • K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION (July 12, 2001)
  • K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION (July 12, 2001)
  • K003402 — WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FO (May 1, 2001)
  • K994321 — STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (October 25, 2000)
  • K974758 — HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (March 9, 1998)
  • K974759 — HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (March 9, 1998)
  • K974397 — STERILE SALINE FOR CATHETER CARE (February 10, 1998)
  • K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION (February 5, 1998)
  • K972372 — GERM TRAPPER SUCTION TUBE HOLDER (December 11, 1997)

FDA data resources