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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Tissue For Aneurysmorrhaphy
510(k) Number K890021
Device Name STERILE POLYHESIVE PBS DRESSING
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Classification Product Code
KGF  
Date Received01/04/1989
Decision Date 06/01/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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