510(k) K800235

ABCO CONNECTING TUBES PRECUT LENGTHS by Abco Dealers, Inc. — Product Code BYY

K800235 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "ABCO CONNECTING TUBES PRECUT LENGTHS". The FDA issued a decision of Substantially Equivalent on February 26, 1980. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
February 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Flexible, Connecting
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type