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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Slide Stainer, Immersion Type
510(k) Number K890984
Device Name LINISTAIN SLS
Applicant
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Applicant Contact CROOKHAM, BA
Correspondent
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Correspondent Contact CROOKHAM, BA
Regulation Number864.3800
Classification Product Code
KIO  
Date Received02/27/1989
Decision Date 04/04/1989
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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