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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 K001264
Device Name EAGLE ENDO SPECIMEN RETRIEVAL BAG
Applicant
EAGLE ENDOSCOPIC, INC.
700 SEALS RD.
BARTONVILLE,  TX  76226
Applicant Contact JOHN MAYALL
Correspondent
EAGLE ENDOSCOPIC, INC.
700 SEALS RD.
BARTONVILLE,  TX  76226
Correspondent Contact JOHN MAYALL
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/19/2000
Decision Date 05/30/2000
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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