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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K971299
Device Name SCIENTIFIC PLASTICS MODEL SP
Applicant
SCIENTIFIC PLASTICS, INC.
243 WEST 30TH ST.
NEW YORK,  NY  10001
Applicant Contact JEFFREY STEGMAN
Correspondent
SCIENTIFIC PLASTICS, INC.
243 WEST 30TH ST.
NEW YORK,  NY  10001
Correspondent Contact JEFFREY STEGMAN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/07/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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