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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 K940317
Device Name SINUSCOPE
Applicant
Stephen Chakoff, Inc.
15405 Southwest 72 Ct.
Miami,  FL  33157
Applicant Contact FRANK GOLDFARB
Correspondent
Stephen Chakoff, Inc.
15405 Southwest 72 Ct.
Miami,  FL  33157
Correspondent Contact FRANK GOLDFARB
Regulation Number874.4760
Classification Product Code
EOB  
Date Received01/24/1994
Decision Date 05/24/1995
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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