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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 K921709
Device Name ENDOBAG, MODIFICATION
Applicant
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Applicant Contact KEITH JUNG
Correspondent
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Correspondent Contact KEITH JUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/10/1992
Decision Date 07/14/1992
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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