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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K871731
Device Name TELSTAR PREWIRE SERIES
Applicant
Telstar Electronics, Inc.
1700 Sunset Dr.
Suite A
Longwood,  FL  32750
Applicant Contact KIM A FISHER
Correspondent
Telstar Electronics, Inc.
1700 Sunset Dr.
Suite A
Longwood,  FL  32750
Correspondent Contact KIM A FISHER
Regulation Number880.5200
Classification Product Code
LRS  
Date Received05/05/1987
Decision Date 10/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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