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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Chemical Solution
510(k) Number K854176
Device Name POLYCHROME IV STAIN
Applicant
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282
Applicant Contact DONALD L PRICE
Correspondent
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282
Correspondent Contact DONALD L PRICE
Regulation Number864.1850
Classification Product Code
LED  
Date Received10/15/1985
Decision Date 10/31/1985
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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