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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K931208
Device Name LOW PROFILE SLEAVE NUT ASSEMBLY
Applicant
Advanced Spine Fixation Systems, Inc.
11095 Knott Ave.
Suite L
Cypress,  CA  90630
Applicant Contact ROBERT S HOWLAND
Correspondent
Advanced Spine Fixation Systems, Inc.
11095 Knott Ave.
Suite L
Cypress,  CA  90630
Correspondent Contact ROBERT S HOWLAND
Regulation Number888.3050
Classification Product Code
KWP  
Date Received03/10/1993
Decision Date 03/28/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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