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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 K894371
Device Name NIPRO SAFELET CATH
Applicant
Pharma-Plast USA, Inc.
26133 Us 19 N
Clearwater,  FL  34623
Applicant Contact LINDEMANN, BOC
Correspondent
Pharma-Plast USA, Inc.
26133 Us 19 N
Clearwater,  FL  34623
Correspondent Contact LINDEMANN, BOC
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/17/1989
Decision Date 10/25/1989
Decision Substantially Equivalent (SESE)
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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