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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 K820362
Device Name REUTER BOBBIN VENTILA. TUBE-TITANIUM
Applicant
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RICHARD'S MEDICAL EQUIP., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.3880
Classification Product Code
ETD  
Date Received02/09/1982
Decision Date 03/02/1982
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
Recalls CDRH Recalls
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