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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, cervical, hygroscopic-laminaria
510(k) Number K021012
Device Name LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Applicant
QUALITY MEDICAL SOLUSIONS LLC
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
QUALITY MEDICAL SOLUSIONS LLC
1308 MORNINGSIDE PARK DR.
ALPHARETTA,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number884.4260
Classification Product Code
HDY  
Date Received03/29/2002
Decision Date 06/25/2002
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
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