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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K021581
Device Name HEMOSORB
Applicant
On Site Gas Systems, Inc.
35 Budney Rd.
Newington,  CT  06111
Applicant Contact FRANCIS X HURSEY
Correspondent
On Site Gas Systems, Inc.
35 Budney Rd.
Newington,  CT  06111
Correspondent Contact FRANCIS X HURSEY
Classification Product Code
QSY  
Date Received05/14/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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