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FDA 510(k) Application Details - K984345
Device Classification Name
Applicator, Ent Drug
More FDA Info for this Device
510(K) Number
K984345
Device Name
Applicator, Ent Drug
Applicant
ENVIS, INC.
25 HERTIAGE DR.
ASHEVILLE, NC 28806 US
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Contact
STEVE WOODY
Other 510(k) Applications for this Contact
Regulation Number
874.5220
More FDA Info for this Regulation Number
Classification Product Code
LRD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/1998
Decision Date
03/19/1999
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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