510(k) K973268

MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM by Microaire Surgical Instruments, Inc. — Product Code BTA

K973268 is an FDA 510(k) premarket notification submitted by Microaire Surgical Instruments, Inc. for the device "MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 1997. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Microaire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1997
Date Received
August 29, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type