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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Oral Cavity
510(k) Number K903718
Device Name OROSCOPE MODEL NUMBER COS-100
Applicant
Cygnus Instruments, Inc.
P.O. Box 60326
Santa Barbara,  CA  93160
Applicant Contact E. M FIRST
Correspondent
Cygnus Instruments, Inc.
P.O. Box 60326
Santa Barbara,  CA  93160
Correspondent Contact E. M FIRST
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received08/16/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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