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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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Decision Date To: 05/01/2024
 
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Device Name
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De Novo
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510(k)
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Decision
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DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC CRANIAL TECHNOLOGIES, INC. DEN980001 K964992 05/29/1998
DIAMOND PROBE/PERIO 2000 SYSTEM DIAMOND GENERAL DEVELOPMENT CORP. DEN980003 K980749 07/17/1998
THE 3PM EGG MACHINE 3PM CO., INC. DEN990005 K984637 08/20/1999
OHMEDA INOVENT DELIVERY SYSTEM OHMEDA MEDICAL DEN000001 K974562 01/11/2000
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE UROSURGE, INC. DEN000002 K992069 02/09/2000
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO WALLAC, INC. DEN990008 K992284 02/15/2000
KAVO DIAGNODENT KAVO AMERICA DEN990002 K983658 02/22/2000
QUICKAIR CHOKE RELIEVER, MODEL 59-001A MAET INDUSTRIES, INC. DEN000004 K993284 02/29/2000
EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. DEN000006 K000280 04/28/2000
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELI INOVA DIAGNOSTICS, INC. DEN000007 K000732 08/16/2000
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