510(k) K790079

NEEDLE, BLOOD COLLECTING by Jelco Laboratories — Product Code GAA

K790079 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "NEEDLE, BLOOD COLLECTING". The FDA issued a decision of Substantially Equivalent on February 1, 1979. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Jelco Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
January 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type