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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K900176
Device Name ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES
Applicant
Machida, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Applicant Contact NORMAN ABRAMS
Correspondent
Machida, Inc.
40 Ramland Rd. S.
Orangeburg,  NY  10962
Correspondent Contact NORMAN ABRAMS
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/12/1990
Decision Date 04/10/1990
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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