510(k) K933232

BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED by Boehringer Laboratories — Product Code KDP

K933232 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1994
Date Received
July 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type