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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Speculum, Vaginal, Nonmetal
510(k) Number K012859
Device Name NU-SPEC D
Applicant
SOL WEISS MD INC
7012 RESEDA BLVD.
SUITE A
RESEDA,  CA  91335
Applicant Contact SOL WEISS
Correspondent
SOL WEISS MD INC
7012 RESEDA BLVD.
SUITE A
RESEDA,  CA  91335
Correspondent Contact SOL WEISS
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/24/2001
Decision Date 10/26/2001
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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