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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 K971995
Device Name MEDIVISION SINOSCOPE
Applicant
Medivision Scope Service Center, Inc.
1440 S. State College Blvd.
#1d
Anaheim,  CA  92806
Applicant Contact WAYNE B STERNER
Correspondent
Medivision Scope Service Center, Inc.
1440 S. State College Blvd.
#1d
Anaheim,  CA  92806
Correspondent Contact WAYNE B STERNER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received05/30/1997
Decision Date 06/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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