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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 K911072
Device Name SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR
Applicant
A & F Products
2808 W. 5th St.
Suite 15
Santa Ana,  CA  92703
Applicant Contact EULER FERRER
Correspondent
A & F Products
2808 W. 5th St.
Suite 15
Santa Ana,  CA  92703
Correspondent Contact EULER FERRER
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received03/11/1991
Decision Date 05/15/1991
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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