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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 K863769
Device Name EVACUATOR TIPS
Applicant
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Applicant Contact CHUCK SMITHSON
Correspondent
The Medical Group, Inc.
4600 Kietzke Ln. L235
Reno,  NV  89502
Correspondent Contact CHUCK SMITHSON
Regulation Number872.6640
Classification Product Code
EHZ  
Date Received09/25/1986
Decision Date 10/30/1986
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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