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510(k) K831920

PLASTIC TUBING CONNECTORS by Polymer Technology Corp. — Product Code BYY

K831920 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "PLASTIC TUBING CONNECTORS". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 14, 1983
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 Polymer Technology Corp.

  • K011945 — RIGID GAS PERMEABLE CONTACT LENS SOLUTION (September 12, 2001)
  • K003932 — BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K002025 — RIGID GAS PERMEABLE CONTACT LENS (October 31, 2000)
  • K001960 — RIGID GAS PERMEABLE CONTACT LENS (August 28, 2000)
  • K000795 — RIGID GAS PERMEABLE CONTACT LENS (May 26, 2000)
  • K980133 — BAUSCH & LOMB WETTING AND SOAKING SOLUTION (March 11, 1998)
  • K974466 — BOSTON ADVANCE CLEANER (February 19, 1998)
  • K973217 — BOSTON LIQUID ENZYMATIC CLEANER (November 24, 1997)
  • K970698 — BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (May 6, 1997)

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