510(k) K901761

STERILE SUCTION TUBING SET by Acacia Laboratories, Inc. — Product Code BYY

K901761 is an FDA 510(k) premarket notification submitted by Acacia Laboratories, Inc. for the device "STERILE SUCTION TUBING SET". The FDA issued a decision of Substantially Equivalent on May 7, 1990. The device falls under product code BYY (Tube, Aspirating, Flexible, Connecting), a Class II device regulated under 21 CFR 880.6740. Acacia Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1990
Date Received
April 18, 1990
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