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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 K933661
Device Name INSUFFLATOR TUBING KIT W/FILTER
Applicant
EAGLE MEDICAL, INC.
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
EAGLE MEDICAL, INC.
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/27/1993
Decision Date 08/25/1993
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
Predetermined Change
Control Plan Authorized		 No
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