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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K983073
Device Name I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
Applicant
INTEGRA BIOTECHNICAL LLC.
105 COPPERWOOD WAY, SUITE A
OCEANSIDE,  CA  92054
Applicant Contact WILLIAM BERGELIN
Correspondent
INTEGRA BIOTECHNICAL LLC.
105 COPPERWOOD WAY, SUITE A
OCEANSIDE,  CA  92054
Correspondent Contact WILLIAM BERGELIN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/02/1998
Decision Date 12/16/1998
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
Predetermined Change
Control Plan Authorized		 No
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