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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 K880189
Device Name NEW JELLIACOAT
Applicant
K&G IMPORT/EXPORT CO.
6417 WESTERN AVE.
WHITTIER,  CA  90606
Applicant Contact GERARD GONZALES
Correspondent
K&G IMPORT/EXPORT CO.
6417 WESTERN AVE.
WHITTIER,  CA  90606
Correspondent Contact GERARD GONZALES
Regulation Number884.5300
Classification Product Code
HIS  
Date Received01/20/1988
Decision Date 06/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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