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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K850800
Device Name DROPSTIRS - PLASTIC DISPOSABLE PIPET
Applicant
Berwick Medical Products, Inc.
P.O. Box 2548
Warminster,  PA  18974
Applicant Contact SUSAN M STOUFFER
Correspondent
Berwick Medical Products, Inc.
P.O. Box 2548
Warminster,  PA  18974
Correspondent Contact SUSAN M STOUFFER
Regulation Number862.2750
Classification Product Code
JQW  
Date Received02/27/1985
Decision Date 04/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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