510(k) K760899

STERILE DISPOSABLE COTTON PLUGGED SER. by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GJW

K760899 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "STERILE DISPOSABLE COTTON PLUGGED SER.". The FDA issued a decision of Substantially Equivalent on November 9, 1976. The device falls under product code GJW (Pipette, Pasteur), a Class I device regulated under 21 CFR 864.6160. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1976
Date Received
October 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pipette, Pasteur
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type