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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Neurosurgical Paddie
510(k) Number K993019
Device Name PACIFIC SURGICAL PATTIES
Applicant
V. Mueller Neuro/Spine
360 Industrial Rd., Unit H
San Carlos,  CA  94070
Applicant Contact TERRY JOHNSTON
Correspondent
V. Mueller Neuro/Spine
360 Industrial Rd., Unit H
San Carlos,  CA  94070
Correspondent Contact TERRY JOHNSTON
Regulation Number882.4700
Classification Product Code
HBA  
Date Received09/08/1999
Decision Date 03/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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