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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 K983716
Device Name VITALCARE DISPOSABLE VAGINAL SPECULUM
Applicant
Vitalcare Group, Inc.
15800 NW 13th Ave.
Miami,  FL  33169
Applicant Contact GINGER TALLEY
Correspondent
Vitalcare Group, Inc.
15800 NW 13th Ave.
Miami,  FL  33169
Correspondent Contact GINGER TALLEY
Regulation Number884.4530
Classification Product Code
HIB  
Date Received10/21/1998
Decision Date 12/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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