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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K892329
Device Name OSMOMETER STANDARD 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 Number862.1150
Classification Product Code
JIT  
Date Received04/05/1989
Decision Date 10/31/1989
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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