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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K894611
Device Name CATHETER CARE KITS
Applicant
L H M Ent., Inc.
237 Dingletown Rd.
Indian Mills,  NJ  08088
Applicant Contact PATRICK J LAMB
Correspondent
L H M Ent., Inc.
237 Dingletown Rd.
Indian Mills,  NJ  08088
Correspondent Contact PATRICK J LAMB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/20/1989
Decision Date 12/15/1989
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General Hospital
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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