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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K213087
Device Name Natural Rubber Latex Ultrasound Transducer Probe Covers
Applicant
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Applicant Contact Christina Cataldo
Correspondent
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Correspondent Contact Christina Cataldo
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/24/2021
Decision Date 06/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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