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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 K944186
Device Name SINUSCOPE
Applicant
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Applicant Contact MARK ZIEGLER
Correspondent
Stryker Endoscopy
210 BAYPOINTE PKWY.
SAN JOSE,  CA  95134
Correspondent Contact MARK ZIEGLER
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/26/1994
Decision Date 11/07/1994
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
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