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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pillow, Cervical (For Mild Sleep Apnea)
510(k) Number K023010
Device Name SNIFF POSITION PILLOWS/POPITZ PILLOWS
Applicant
AEOLUS INTERNATIONAL CORPORATION
64 INDIAN COVE RD.
MARION,  MA  02738 -2113
Applicant Contact MICHAEL D POPITZ
Correspondent
AEOLUS INTERNATIONAL CORPORATION
64 INDIAN COVE RD.
MARION,  MA  02738 -2113
Correspondent Contact MICHAEL D POPITZ
Regulation Number872.5570
Classification Product Code
MYB  
Date Received09/09/2002
Decision Date 10/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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