SENSUA!


Device Classification Name

condom

510(k) Number K021125
Device Name SENSUA!
Original Applicant
AAC CONSULTING GROUP, INC.
7361 calhoun pl.#500
rockville, 
MD 
20855 -2774

Original Contact eduardo march
Regulation Number 884.5300
Classification Product Code
HIS  
Subsequent Product Code
KMJ  
Date Received 04/08/2002
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