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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uroflowmeter
510(k) Number K951442
Device Name FLOLAB
Applicant
Synectics Medical, Inc.
Renstienas Gata 12, 5tr.
S-116 28 Stockholm,  SE S-11628
Applicant Contact ANNA PETTERSSON
Correspondent
Synectics Medical, Inc.
Renstienas Gata 12, 5tr.
S-116 28 Stockholm,  SE S-11628
Correspondent Contact ANNA PETTERSSON
Regulation Number876.1800
Classification Product Code
EXY  
Date Received03/29/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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