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FDA 510(k) Application Details - K093296
Device Classification Name
Ring (Wound Protector), Drape Retention, Internal
More FDA Info for this Device
510(K) Number
K093296
Device Name
Ring (Wound Protector), Drape Retention, Internal
Applicant
APPLIED MEDICAL RESOURCES CORP.
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
Other 510(k) Applications for this Company
Contact
FRANS VANDENBROEK
Other 510(k) Applications for this Contact
Regulation Number
878.4370
More FDA Info for this Regulation Number
Classification Product Code
KGW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2009
Decision Date
11/05/2009
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
Y
Expedited Review
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