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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter And Tip, Suction
510(k) Number K893527
Device Name LAPAROSCOPIC SUCTION PROBE
Applicant
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Applicant Contact MARY K BRUCH
Correspondent
Dexide, Inc.
P.O. Box 185789
Fort Worth,  TX  76181
Correspondent Contact MARY K BRUCH
Regulation Number880.6740
Classification Product Code
JOL  
Date Received05/08/1989
Decision Date 07/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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