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FDA 510(k) Application Details - K223051
Device Classification Name
Elastomer, Silicone Block
More FDA Info for this Device
510(K) Number
K223051
Device Name
Elastomer, Silicone Block
Applicant
International Medical Devices, Inc.
717 North Maple Drive
Beverly Hills, CA 90210 US
Other 510(k) Applications for this Company
Contact
Dr. James Elist
Other 510(k) Applications for this Contact
Regulation Number
874.3620
More FDA Info for this Regulation Number
Classification Product Code
MIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2022
Decision Date
02/03/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
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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