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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 K132668
Device Name IOB DISPOSABLE SPECULUM
Applicant
Iob Medical, Inc.
504 E. Diamond Ave., Suite F
Gaithersburg,  MD  20877
Applicant Contact JOE XIA
Correspondent
Iob Medical, Inc.
504 E. Diamond Ave., Suite F
Gaithersburg,  MD  20877
Correspondent Contact JOE XIA
Regulation Number884.4530
Classification Product Code
HIB  
Date Received08/27/2013
Decision Date 01/17/2014
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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