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FDA 510(k) Application Details - K203052
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K203052
Device Name
Sleeve, Limb, Compressible
Applicant
Recovery Force, LLC
10022 Lantern Rd., Suite 100
Fishers, IN 46037 US
Other 510(k) Applications for this Company
Contact
Jeff Schwegman
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2020
Decision Date
03/21/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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