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FDA 510(k) Application Details - K222552
Device Classification Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
More FDA Info for this Device
510(K) Number
K222552
Device Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant
Stryker Instruments
1941 Stryker Way
Portage, MI 49002 US
Other 510(k) Applications for this Company
Contact
Tu Nguyen
Other 510(k) Applications for this Contact
Regulation Number
878.4780
More FDA Info for this Regulation Number
Classification Product Code
JCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/23/2022
Decision Date
12/09/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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