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FDA 510(k) Application Details - K062907
Device Classification Name
Ring (Wound Protector), Drape Retention, Internal
More FDA Info for this Device
510(K) Number
K062907
Device Name
Ring (Wound Protector), Drape Retention, Internal
Applicant
APPLIED MEDICAL RESOURCES
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688 US
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Contact
CHERYL BLAKE
Other 510(k) Applications for this Contact
Regulation Number
878.4370
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Classification Product Code
KGW
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More FDA Info for this Product Code
Date Received
09/27/2006
Decision Date
01/09/2007
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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