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FDA 510(k) Application Details - K193336
Device Classification Name
Oral Wound Dressing
More FDA Info for this Device
510(K) Number
K193336
Device Name
Oral Wound Dressing
Applicant
Synedgen, Inc.
1420 North Claremont Blvd. Suite 105D
Claremont, CA 91711 US
Other 510(k) Applications for this Company
Contact
Shenda Baker
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OLR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2019
Decision Date
05/27/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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