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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tympanostomy
510(k) Number K011383
Device Name MICRODOSE CATH, MODELS 90121-201, -202, -203
Applicant
DURECT CORP.
10240 BUBB RD.
CUPERTINO,  CA  95014
Applicant Contact JEFF P MILLER
Correspondent
DURECT CORP.
10240 BUBB RD.
CUPERTINO,  CA  95014
Correspondent Contact JEFF P MILLER
Regulation Number874.3880
Classification Product Code
ETD  
Date Received05/07/2001
Decision Date 06/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
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