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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K864121
Device Name PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
Applicant
Pharmatrol, Inc.
1801 E. 12th St.
Suite # 220
Cleveland,  OH  44114
Applicant Contact MARK J HASSETT
Correspondent
Pharmatrol, Inc.
1801 E. 12th St.
Suite # 220
Cleveland,  OH  44114
Correspondent Contact MARK J HASSETT
Regulation Number868.1890
Classification Product Code
NDC  
Date Received10/21/1986
Decision Date 12/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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