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510(k) K830571

BOTTLE ADAPTER by Burron Medical Products, Inc. — Product Code KYX

K830571 is an FDA 510(k) premarket notification submitted by Burron Medical Products, Inc. for the device "BOTTLE ADAPTER". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Burron Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Liquid Medication
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type

Other clearances by Burron Medical Products, Inc.

  • K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
  • K862412 — INTESTOPLANT (November 13, 1986)
  • K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
  • K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
  • K851293 — IMPLANTOFIX (January 9, 1986)
  • K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
  • K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
  • K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
  • K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
  • K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)

Other clearances for product code KYX

  • K143177 — KleenGel Dispenser (September 14, 2015)
  • K980109 — CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (August 18, 1998)
  • K954181 — CANYONS BI-DIRECTIONAL CHECK VALVE (November 29, 1995)
  • K801008 — MULTI-AD FLUID DISPENSING PUMP MP-3000 (June 2, 1980)
  • K800437 — SYRINGE TIP CONNECTOR (March 12, 1980)
  • K800362 — FLUID DISPENSING SYSTEM (March 12, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)
  • K781364 — PINT BOTTLE WELL (October 17, 1978)
  • K771539 — STEPPER (October 7, 1977)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)

FDA data resources