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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Central Multiple Patient
510(k) Number K870889
Device Name ACID FUCHSIN SOLUTIONS
Applicant
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Applicant Contact ADOLPH E D'AMICO
Correspondent
D.R.G. Scientific Industries
1140 Saratoga St.
East Boston,  MA  02128
Correspondent Contact ADOLPH E D'AMICO
Regulation Number876.5820
Classification Product Code
FKQ  
Date Received03/05/1987
Decision Date 07/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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