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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 K912343
Device Name DISTENDABLE PALPATION PROBE
Applicant
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Applicant Contact J.KEITH JUNG
Correspondent
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Correspondent Contact J.KEITH JUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/28/1991
Decision Date 06/18/1991
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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