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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, physical/chemical sterilization process
510(k) Number K897045
Device Name BOWIE-DICK TEST CARD CATALOG NUMBER 008018
Applicant
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Applicant Contact GLENN MATTEI
Correspondent
EDWARD WECK, INC.
P.O. BOX 12600
WECK DRIVE
RESEARCH TRIANGLE PA,  NC  27709
Correspondent Contact GLENN MATTEI
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received12/19/1989
Decision Date 02/15/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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