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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cotton, Roll
510(k) Number K863764
Device Name COTTON ROLLS, NON-STERILE
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 Number872.6050
Classification Product Code
EFN  
Date Received09/25/1986
Decision Date 10/27/1986
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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