FDA 510(k) Application Details - K023010

Device Classification Name Pillow,Cervical(For Mild Sleep Apnea)

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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
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Regulation Number 872.5570

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Classification Product Code MYB
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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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