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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K883115
Device Name PMT SUBARACHNOID SCREW, MODEL NO.1350-2
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact AL IVERSEN
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact AL IVERSEN
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/25/1988
Decision Date 08/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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