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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K004016
Device Name SHEER THIN AROMAS BLUE LATEX CONDOM
Applicant
EAGLE TWE, INC.
2090 TUCKER INDUSTRIAL RD.
TUCKER,  GA  30084
Applicant Contact KEITH F HEINTZ
Correspondent
EAGLE TWE, INC.
2090 TUCKER INDUSTRIAL RD.
TUCKER,  GA  30084
Correspondent Contact KEITH F HEINTZ
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/27/2000
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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