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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snake Bite Suction Kit
510(k) Number K883839
Device Name ND:YAG LASER SPECTACLES, MST MODEL #YLS-5
Applicant
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact SCOTT C MARLOW
Correspondent
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact SCOTT C MARLOW
Regulation Number880.5740
Classification Product Code
KYP  
Date Received09/12/1988
Decision Date 12/09/1988
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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