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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K843448
Device Name SCIMED PM200 INFLATION MANOMETER
Applicant
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Applicant Contact DARLENE A THOMETZQ
Correspondent
Scimed Life Systems, Inc.
13000 County Rd. 6
Minneapolis,  MN  55441
Correspondent Contact DARLENE A THOMETZQ
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/05/1984
Decision Date 10/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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