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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
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