510(k) K874504

MICRO-AIRE PULSE LAVAGE by Micro-Aire Surgical Instruments, Inc. — Product Code FQH

K874504 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE PULSE LAVAGE". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type