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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K011341
Device Name LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
Applicant
Lh Medical Products, Inc.
301 E. Arrow Hwy., Suite 104
San Dimas,  CA  91773
Applicant Contact LONNIE HUTSON
Correspondent
Lh Medical Products, Inc.
301 E. Arrow Hwy., Suite 104
San Dimas,  CA  91773
Correspondent Contact LONNIE HUTSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/02/2001
Decision Date 09/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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