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FDA 510(k) Application Details - K991587
Device Classification Name
Prosthesis, Laryngeal (Taub)
More FDA Info for this Device
510(K) Number
K991587
Device Name
Prosthesis, Laryngeal (Taub)
Applicant
HELIX MEDICAL, INC.
1110 MARK AVE.
CARPINTERIA, CA 93013 US
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Contact
CYNTHIA ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
874.3730
More FDA Info for this Regulation Number
Classification Product Code
EWL
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More FDA Info for this Product Code
Date Received
05/07/1999
Decision Date
06/25/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
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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