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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hematoxylin Harris'S
510(k) Number K873107
Device Name INSTANT HEMATOXYLIN
Applicant
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Applicant Contact JANET N CROOKHAM,BA
Correspondent
Shandon, Inc.
171 Industry Dr.
Pittsburgh,  PA  15275
Correspondent Contact JANET N CROOKHAM,BA
Regulation Number864.1850
Classification Product Code
HYK  
Date Received08/07/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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