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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, hypodermic, single lumen
510(k) Number K971763
Device Name BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
Applicant
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LANE, P.O. BOX 9
LITTLE ELM,  TX  75068 -0009
Applicant Contact TERANCE GRISSO
Correspondent
RETRACTABLE TECHNOLOGIES, INC.
511 LOBO LANE, P.O. BOX 9
LITTLE ELM,  TX  75068 -0009
Correspondent Contact TERANCE GRISSO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/13/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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