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510(k) K192100

Aveta Disposable Hysteroscope by Meditrina, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2019
Date Received
August 5, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Meditrina, Inc.

  • K223813 — Aveta System 2.0 (August 21, 2023)
  • K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable (May 26, 2022)
  • K191958 — Aveta System (October 1, 2019)
  • K190372 — Aveta System (May 16, 2019)

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