510(k) K934014

VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT by Biotrol, USA, Inc. — Product Code LRJ

K934014 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
August 17, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type