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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K911149
Device Name PAL (PROBE FOR ASPIRATION AND LAVAGE)
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 Number876.1500
Classification Product Code
GCJ  
Date Received03/15/1991
Decision Date 07/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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