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510(k) K231489

Sturdy Autoclave Super Microm by Sturdy Industrial Co., Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2023
Date Received
May 23, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Sturdy Industrial Co., Ltd.

  • K181993 — STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) (November 1, 2019)
  • K032596 — STURDY MANUAL RESUSCITATOR (August 5, 2004)

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