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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K940913
Device Name SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM
Applicant
Spine-Tech, Inc.
980 E. Hennepin Ave.
Minneapolis,  MN  55414
Applicant Contact RICHARD JANSEN
Correspondent
Spine-Tech, Inc.
980 E. Hennepin Ave.
Minneapolis,  MN  55414
Correspondent Contact RICHARD JANSEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/25/1994
Decision Date 10/04/1994
Decision Substantially Equivalent (SESE)
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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