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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 K013817
Device Name GLO-SPEC
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 Received11/16/2001
Decision Date 12/21/2001
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
Predetermined Change
Control Plan Authorized		 No
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