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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Engorgement, Clitoral
510(k) Number K001576
Device Name EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY
Applicant
PROSURG, INC.
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Applicant Contact LEE BUI
Correspondent
PROSURG, INC.
2193 TRADE ZONE BLVD.
SAN JOSE,  CA  95131
Correspondent Contact LEE BUI
Regulation Number884.5970
Classification Product Code
NBV  
Date Received05/22/2000
Decision Date 12/28/2000
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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