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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, Automated
510(k) Number K850333
Device Name PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
Applicant
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Applicant Contact BARBARA H SNEADE
Correspondent
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Correspondent Contact BARBARA H SNEADE
Regulation Number864.3800
Classification Product Code
KPA  
Date Received01/28/1985
Decision Date 02/27/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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