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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 K002912
Device Name VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073
Applicant
Sterinc
3520 W. Warner Ave.
Santa Ana,  CA  92704
Applicant Contact TODD ABRAHAM
Correspondent
Sterinc
3520 W. Warner Ave.
Santa Ana,  CA  92704
Correspondent Contact TODD ABRAHAM
Regulation Number884.4530
Classification Product Code
HIB  
Date Received09/18/2000
Decision Date 02/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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