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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 K013390
Device Name QUICKCLOT
Applicant
On Site Gas Systems, Inc.
35 Budney Rd.
Newington,  CT  06111
Applicant Contact C. BURTON GULLONG
Correspondent
On Site Gas Systems, Inc.
35 Budney Rd.
Newington,  CT  06111
Correspondent Contact C. BURTON GULLONG
Classification Product Code
QSY  
Date Received10/15/2001
Decision Date 05/23/2002
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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