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510(k) K250172

Green Card Bowie-Dick Test (BD115) by Steritec Products, Inc. (A Getinge Company) — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
January 21, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

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