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FDA 510(k) Application Details - K223098
Device Classification Name
Intrauterine Tamponade Balloon
More FDA Info for this Device
510(K) Number
K223098
Device Name
Intrauterine Tamponade Balloon
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, IN 47402 US
Other 510(k) Applications for this Company
Contact
Ian Herman
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
OQY
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More FDA Info for this Product Code
Date Received
09/30/2022
Decision Date
10/28/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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