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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 K892881
Device Name DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101
Applicant
Nieusma R & D, Inc.
13658 Hanford Court
Warren,  MI  48093
Applicant Contact NIEUSMA, JR
Correspondent
Nieusma R & D, Inc.
13658 Hanford Court
Warren,  MI  48093
Correspondent Contact NIEUSMA, JR
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received04/06/1989
Decision Date 06/23/1989
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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