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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 K812460
Device Name VARIOUS AURAL GROMMETS
Applicant
EXMOOR PLASTICS LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
EXMOOR PLASTICS LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/31/1981
Decision Date 09/21/1981
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
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