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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 K932869
Device Name ARTHROPLANE
Applicant
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Applicant Contact CAROL LAUFENBURG
Correspondent
Synvasive Technology, Inc.
11328 Sunrise Gold Cir.
Rancho Cordova,  CA  95742
Correspondent Contact CAROL LAUFENBURG
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
KIJ  
Date Received06/14/1993
Decision Date 03/25/1994
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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