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FDA 510(k) Application Details - K981704
Device Classification Name
Masker, Tinnitus
More FDA Info for this Device
510(K) Number
K981704
Device Name
Masker, Tinnitus
Applicant
ADM TRONICS UNLTD, INC.
P.O. BOX 2002
MORRISTOWN, TN 37816 US
Other 510(k) Applications for this Company
Contact
JAMES E LENICK
Other 510(k) Applications for this Contact
Regulation Number
874.3400
More FDA Info for this Regulation Number
Classification Product Code
KLW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/14/1998
Decision Date
08/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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