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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K971849
Device Name CYTOLOGY BRUSH
Applicant
Team Technologies, Inc.
5949 Commerce Blvd.
Morristown,  TN  37814
Applicant Contact BOB WALTON
Correspondent
Team Technologies, Inc.
5949 Commerce Blvd.
Morristown,  TN  37814
Correspondent Contact BOB WALTON
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/19/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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