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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 K760103
Device Name CAP, INJECTION (#4600)
Applicant
JELCO LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JELCO LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/23/1976
Decision Date 07/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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