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510(k) K843470

PHARMA-PLAST CONNECTING TUBE TYPE SUCT- by Zimmar Consulting , Ltd. — Product Code BYY

K843470 is an FDA 510(k) premarket notification submitted by Zimmar Consulting , Ltd. for the device "PHARMA-PLAST CONNECTING TUBE TYPE SUCT-". The FDA issued a decision of Substantially Equivalent on November 16, 1984. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Zimmar Consulting , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Zimmar Consulting , Ltd.

  • K860322 — CLINISET INFUSION SET (April 7, 1986)
  • K843477 — PHARMA-PLAST RECTAL TIP (December 5, 1984)
  • K843478 — PHARMA-PLAST URIDROP-URIDOME (December 5, 1984)
  • K843468 — PHARMA-PLAST SUCTION SET TYPE YANKAUER (November 23, 1984)
  • K843466 — PHARMA-PLAST OXYGEN CATHETER (November 19, 1984)
  • K843467 — PHARMA-PLAST NASAL OXYGEN CANNULA (November 19, 1984)
  • K843469 — PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (November 19, 1984)
  • K843475 — PHARMA-PLAST SINGLE USE OVERSHOES (October 31, 1984)
  • K843472 — PHARMA-PLAST SYRINGE WITH NEEDLE (October 31, 1984)
  • K843471 — PHARMA-PLAST SYRINGE (October 31, 1984)

Other clearances for product code BYY

  • K960616 — VITAFLOW SUCTION/ASPIRATION TUBING SET (May 6, 1996)
  • K960218 — CONNECTING TUBING (March 28, 1996)
  • K955151 — MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (January 24, 1996)
  • K955149 — MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (January 24, 1996)
  • K955150 — MAXI-FLOW (January 23, 1996)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K911586 — GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (July 2, 1991)
  • K901761 — STERILE SUCTION TUBING SET (May 7, 1990)
  • K873463 — VAN DELLEN ASPIRATING TUBING (November 23, 1987)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)

FDA data resources