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FDA 510(k) Application Details - K040161
Device Classification Name
Pillow,Cervical(For Mild Sleep Apnea)
More FDA Info for this Device
510(K) Number
K040161
Device Name
Pillow,Cervical(For Mild Sleep Apnea)
Applicant
SLEEP DEVICES, INC.
720 WEST OAK STREET
SUITE 210
KISSIMMEE, FL 34741 US
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Contact
NAJEEB A ZUBERI
Other 510(k) Applications for this Contact
Regulation Number
872.5570
More FDA Info for this Regulation Number
Classification Product Code
MYB
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More FDA Info for this Product Code
Date Received
01/23/2004
Decision Date
04/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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