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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 K940785
Device Name MOUTH PROPS
Applicant
Worldwide Dental, Inc.
12890 Automobile Blvd.,
Suite A
Clearwater,  FL  34622 -4733
Applicant Contact WILLIAM M DOMIN
Correspondent
Worldwide Dental, Inc.
12890 Automobile Blvd.,
Suite A
Clearwater,  FL  34622 -4733
Correspondent Contact WILLIAM M DOMIN
Regulation Number872.4565
Classification Product Code
EIF  
Date Received02/22/1994
Decision Date 10/05/1994
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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