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510(k) K190105

ZOOM Aspiration Pump by Taiwan Biomaterial Co., Ltd. — Product Code JCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2019
Date Received
January 22, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

Other clearances by Taiwan Biomaterial Co., Ltd.

  • K180115 — TWBM Pump (July 24, 2018)

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  • K182950 — Acare Suction Unit (August 23, 2019)
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  • K180115 — TWBM Pump (July 24, 2018)
  • K181398 — DV-300 Aspirator (July 23, 2018)
  • K172481 — IntelliCart System (September 14, 2017)