FDA 510(k) Application Details - K990871

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

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510(K) Number K990871
Device Name Pillow,Cervical(For Mild Sleep Apnea)
Applicant LIFESLEEP SYSTEMS, INC.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact HOWARD M HOLSTEIN
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Regulation Number 872.5570

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Classification Product Code MYB
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Date Received 03/16/1999
Decision Date 06/10/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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