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FDA 510(k) Application Details - K192667
Device Classification Name
More FDA Info for this Device
510(K) Number
K192667
Device Name
gel-e Flex+ gel OTC
Applicant
gel-e, Inc.
387 Technology Dr., Suite 3110B
College Park, MD 20742 US
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Contact
Elsa Abruzzo
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QSY
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More FDA Info for this Product Code
Date Received
09/25/2019
Decision Date
10/25/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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