Model 1700, Hydro Prep

• • Terminated Z-0675-2020 FDA Class II ·initiated 7 Nov 2019 ·on shared 510(k) K970694

  Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

• 2 recalls, same reason

  • Terminated Z-0705-2020 FDA Class II ·initiated 29 Oct 2019 ·on shared 510(k) K970694
  • Terminated Z-0704-2020 FDA Class II ·initiated 29 Oct 2019 ·on shared 510(k) K970694

  Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K970694 ↗

FDA Product Code

GYB

Device Class

Class II

Regulation

21 CFR Part 882.1275

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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