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510(k) DEN230011

OcuCool by Recensmedical, Inc. — Product Code QZQ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 30, 2024
Date Received
February 16, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Other clearances by Recensmedical, Inc.

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  • K221234 — TargetCool (July 22, 2022)
  • K220674 — TargetCool (March 31, 2022)
  • K203481 — CryoVIVE (May 13, 2021)