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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 K102742
Device Name NASAL CEASE
Applicant
Catalina, Inc.
8110 Westbury Dr.
Richmond,  VA  23229
Applicant Contact RICHARD J FREER
Correspondent
Catalina, Inc.
8110 Westbury Dr.
Richmond,  VA  23229
Correspondent Contact RICHARD J FREER
Classification Product Code
QSY  
Date Received09/22/2010
Decision Date 02/02/2011
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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