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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 K001994
Device Name EEI SLUSH PAN DRAPE
Applicant
Eagle Endoscopic, Inc.
700 Seals Rd.
Bartonville,  TX  76226
Applicant Contact JOHN MAYALL
Correspondent
Eagle Endoscopic, Inc.
700 Seals Rd.
Bartonville,  TX  76226
Correspondent Contact JOHN MAYALL
Regulation Number878.4370
Classification Product Code
KKX  
Date Received06/30/2000
Decision Date 08/04/2000
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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