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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, catheter
510(k) Number K974146
Device Name PARACENTESIS CATHETER DEVICE
Applicant
ALLEGIANCE HEALTHCARE CORP.
1435 LAKE COOK RD.
DEERFIELD,  IL  60015
Applicant Contact SHARON ROBBINS
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1435 LAKE COOK RD.
DEERFIELD,  IL  60015
Correspondent Contact SHARON ROBBINS
Regulation Number878.4200
Classification Product Code
GCB  
Date Received11/03/1997
Decision Date 01/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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