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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K042666
Device Name LUTH-ALL SUB-Q NEEDLE SET
Applicant
Luth-All Medical Products, LLC
28303 Cabot Rd. Suite 300
Laguna Niguel,  CA  92677
Applicant Contact SHEPARD G BENTLEY
Correspondent
Luth-All Medical Products, LLC
28303 Cabot Rd. Suite 300
Laguna Niguel,  CA  92677
Correspondent Contact SHEPARD G BENTLEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/29/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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