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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 K932979
Device Name EXTERNAL STABILITY PAD
Applicant
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Applicant Contact DAVID PHELPS
Correspondent
LOUISVILLE LABORATORIES, INC.
2400 CRITTENDEN DR.
LOUISVILLE,  KY  40217 -1865
Correspondent Contact DAVID PHELPS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/17/1993
Decision Date 11/02/1993
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
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