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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 K021125
Device Name SENSUA!
Applicant
AAC CONSULTING GROUP, INC.
7361 CALHOUN PL.#500
rockville,  MD  20855 -2774
Applicant Contact eduardo march
Correspondent
AAC CONSULTING GROUP, INC.
7361 CALHOUN PL.#500
rockville,  MD  20855 -2774
Correspondent Contact eduardo march
Regulation Number884.5300
Classification Product Code
HIS  
Subsequent Product Code
KMJ  
Date Received04/08/2002
Decision Date 10/25/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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