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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 K780701
Device Name DENTAL OFFICE ENVIRONMENT CONTROL UNIT
Applicant
Laminaire Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Laminaire Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received04/26/1978
Decision Date 05/16/1978
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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