The following data is part of a premarket notification filed by Microaire Surgical Instruments, Inc. with the FDA for Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri.
Device ID | K981922 |
510k Number | K981922 |
Device Name: | LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI |
Classification | System, Suction, Lipoplasty |
Applicant | MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
Contact | Carl Angles |
Correspondent | Carl Angles MICROAIRE SURGICAL INSTRUMENTS, INC. 1641 EDLICH DR. Charlottesville, VA 22911 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-01 |
Decision Date | 1998-12-10 |
Summary: | summary |