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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K001175
Device Name SERAGARD VASCULAR ACCESS PATCH
Applicant
Platinum Services, Inc.
115 Boise St.
Dequincy,  LA  70633
Applicant Contact NANCY Y STREET
Correspondent
Platinum Services, Inc.
115 Boise St.
Dequincy,  LA  70633
Correspondent Contact NANCY Y STREET
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/11/2000
Decision Date 09/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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