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FDA 510(k) Application Details - K023010
Device Classification Name
Pillow,Cervical(For Mild Sleep Apnea)
More FDA Info for this Device
510(K) Number
K023010
Device Name
Pillow,Cervical(For Mild Sleep Apnea)
Applicant
AEOLUS INTERNATIONAL CORPORATION
64 INDIAN COVE RD.
MARION, MA 02738-2113 US
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Contact
MICHAEL D POPITZ
Other 510(k) Applications for this Contact
Regulation Number
872.5570
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Classification Product Code
MYB
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More FDA Info for this Product Code
Date Received
09/09/2002
Decision Date
10/01/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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