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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Albumin-Based
510(k) Number K890022
Device Name ATS MAYER'S ALBUMIN
Applicant
Alpha-Tec Systems, Inc.
18271 Mcdurmott W., Suite I
Irvine,  CA  92714
Applicant Contact LAURIE A WILLIAMS
Correspondent
Alpha-Tec Systems, Inc.
18271 Mcdurmott W., Suite I
Irvine,  CA  92714
Correspondent Contact LAURIE A WILLIAMS
Regulation Number864.4010
Classification Product Code
KEL  
Date Received01/04/1989
Decision Date 01/10/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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