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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Operating-Room, Wall Vacuum Powered
510(k) Number K920248
Device Name MODEL SLASE 210 HOLMIUM LASER SYSTEM
Applicant
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact CHARLES L ROSE
Correspondent
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact CHARLES L ROSE
Regulation Number880.6740
Classification Product Code
GCX  
Date Received01/21/1992
Decision Date 07/21/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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