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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Pressure Measurement, Intermittent
510(k) Number K925258
Device Name DYNAMIC PRESSURE MONITOR 2000M AND 2000C
Applicant
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Applicant Contact MICHAEL SILVERMAN
Correspondent
Pin Dot Products, Inc.
6001 Gross Pt. Rd.
Niles,  IL  60648
Correspondent Contact MICHAEL SILVERMAN
Regulation Number890.1600
Classification Product Code
JFC  
Date Received10/19/1992
Decision Date 03/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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