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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K071225
Device Name INNOVASA STAT*SEAL TOPICAL HEMOSTAT
Applicant
Innovasa, Inc.
16625 Redmond Way
Pmb M-316
Redmond,  WA  98052
Applicant Contact Roberta Hines
Correspondent
Innovasa, Inc.
16625 Redmond Way
Pmb M-316
Redmond,  WA  98052
Correspondent Contact Roberta Hines
Regulation Number870.4450
Classification Product Code
DXC  
Date Received05/02/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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