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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K060097
Device Name GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
Applicant
KLS-Martin L.P.
11239 St. Johns Industrial
Pkwy. S.
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
11239 St. Johns Industrial
Pkwy. S.
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number882.4800
Classification Product Code
GZT  
Date Received01/13/2006
Decision Date 02/27/2006
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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