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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Masker, Tinnitus
510(k) Number K940567
Device Name MODEL#1550 MARSONA(R) TINNITUS MASKER
Applicant
Marpac, Inc.
2907 Blue Clay Rd.
P.O. Box 3098
Wilmington,  NC  28406
Applicant Contact DAVID A THEISEN
Correspondent
Marpac, Inc.
2907 Blue Clay Rd.
P.O. Box 3098
Wilmington,  NC  28406
Correspondent Contact DAVID A THEISEN
Regulation Number874.3400
Classification Product Code
KLW  
Date Received02/08/1994
Decision Date 07/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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