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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K932857
Device Name ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC.
Applicant
Ansley Medical Products, Inc.
13737 Stemmons Fwy.
Dallas,  TX  75234
Applicant Contact SHARON CHEATWOOD
Correspondent
Ansley Medical Products, Inc.
13737 Stemmons Fwy.
Dallas,  TX  75234
Correspondent Contact SHARON CHEATWOOD
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/10/1993
Decision Date 09/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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