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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 K953993
Device Name TYMPASNOSTOMY TUBE
Applicant
Hampton Precision Products, Inc.
277 Haas Ln.
Fenton,  MO  63026
Applicant Contact HETTY TANCSA
Correspondent
Hampton Precision Products, Inc.
277 Haas Ln.
Fenton,  MO  63026
Correspondent Contact HETTY TANCSA
Regulation Number874.3880
Classification Product Code
ETD  
Date Received08/24/1995
Decision Date 09/12/1995
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
Predetermined Change
Control Plan Authorized		 No
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