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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name breast implant suction retrieval device
De Novo Number DEN220082
Device Name Breast Implant Removal Device (BIRD)
Requester
gaylord solutions, llc
1258 old 27 n
gaylord,  MI  49735
Contact alex cerveniak
Regulation Number878.4675
Classification Product Code
QVS  
Date Received11/21/2022
Decision Date 04/20/2023
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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