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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 K895245
Device Name FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
Applicant
Optimed Technologies, Inc.
17991 Fitch
Irvine,  CA  92714
Applicant Contact EHMSEN, SCD
Correspondent
Optimed Technologies, Inc.
17991 Fitch
Irvine,  CA  92714
Correspondent Contact EHMSEN, SCD
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/21/1989
Decision Date 11/17/1989
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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