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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K970187
Device Name RUNYON LARGE VOLUME PARACENTESIS KIT
Applicant
GI SUPPLY
P.O. BOX 289
WILLINGTON,  CT  06279
Applicant Contact ROBERT G WHALEN
Correspondent
GI SUPPLY
P.O. BOX 289
WILLINGTON,  CT  06279
Correspondent Contact ROBERT G WHALEN
Regulation Number878.4370
Classification Product Code
LRO  
Date Received01/17/1997
Decision Date 02/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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