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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 K041757
Device Name FEMSPEC DISPOSABLE VAGINAL SPECULUM
Applicant
Femspec LLC
220 Halleck St., Suite 120
P.O. Box 29450
San Francisco,  CA  94129 -0450
Applicant Contact GERALD JAY SANDERS
Correspondent
Femspec LLC
220 Halleck St., Suite 120
P.O. Box 29450
San Francisco,  CA  94129 -0450
Correspondent Contact GERALD JAY SANDERS
Regulation Number884.4530
Classification Product Code
HIB  
Date Received06/29/2004
Decision Date 12/23/2004
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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