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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K041504
Device Name HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
Applicant
Haemacure Corp.
7113 River Club Blvd.,
Brandenton,  FL  34202
Applicant Contact ELAINE WHITMORE
Correspondent
Haemacure Corp.
7113 River Club Blvd.,
Brandenton,  FL  34202
Correspondent Contact ELAINE WHITMORE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/07/2004
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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