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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
Applicant Contact EDUARDO MARCH
Correspondent
Aac Consulting Group, Inc.
7361 Calhoun Pl.#500
Rockville,  MD  20855
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
Predetermined Change
Control Plan Authorized		 No
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