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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K945956
Device Name STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
Applicant
Strato Medical Corp.
123 Brimbal Ave.
Beverly,  MA  01915
Applicant Contact CRAIG M AUDET
Correspondent
Strato Medical Corp.
123 Brimbal Ave.
Beverly,  MA  01915
Correspondent Contact CRAIG M AUDET
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/06/1994
Decision Date 06/06/1995
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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