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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Retractor, Dental
510(k) Number K873960
Device Name LEWIS SAFE SLEEVE
Applicant
Cheri Lewis, D.D.S.
240 S. La Cienega Blvd.
Suite 301
Beverly Hills,  CA  90211
Applicant Contact LEWIS, D.D.S.
Correspondent
Cheri Lewis, D.D.S.
240 S. La Cienega Blvd.
Suite 301
Beverly Hills,  CA  90211
Correspondent Contact LEWIS, D.D.S.
Regulation Number872.4565
Classification Product Code
EIF  
Date Received09/28/1987
Decision Date 12/04/1987
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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