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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lift, Patient, Non-Ac-Powered
510(k) Number K942807
Device Name SURGICAL LIFT SHEET
Applicant
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Applicant Contact DON HAAS
Correspondent
Surgin Surgical Instrumentation, Inc.
14762 Bentley Cir.
Tustin,  CA  92680
Correspondent Contact DON HAAS
Regulation Number880.5510
Classification Product Code
FSA  
Date Received06/14/1994
Decision Date 08/02/1994
Decision Substantially Equivalent (SESE)
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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