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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Specialized Obstetric-Gynecologic
510(k) Number K951081
Device Name OB/GYN PACKS
Applicant
STERILE CONCEPTS, INC.
5100 COMMERCE RD..
RICHMOND,  VA  23234
Applicant Contact DARREN REEVES
Correspondent
STERILE CONCEPTS, INC.
5100 COMMERCE RD..
RICHMOND,  VA  23234
Correspondent Contact DARREN REEVES
Regulation Number884.4530
Classification Product Code
KNA  
Date Received03/09/1995
Decision Date 11/13/1995
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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