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510(k) K213087

Natural Rubber Latex Ultrasound Transducer Probe Covers by Global Protection Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2022
Date Received
September 24, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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