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FDA 510(k) Application Details - K221653
Device Classification Name
Pack, Hot Or Cold, Disposable
More FDA Info for this Device
510(K) Number
K221653
Device Name
Pack, Hot Or Cold, Disposable
Applicant
International Biomedical
8206 Cross Park Drive
Austin, TX 78754 US
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Contact
Amy Pieper
Other 510(k) Applications for this Contact
Regulation Number
890.5710
More FDA Info for this Regulation Number
Classification Product Code
IMD
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More FDA Info for this Product Code
Date Received
06/07/2022
Decision Date
10/06/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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