The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Microaire Surgical Instruments Llc.
Device ID | K113128 |
510k Number | K113128 |
Device Name: | MICROAIRE SURGICAL INSTRUMENTS LLC |
Classification | System, Suction, Lipoplasty |
Applicant | MICROAIRE SURGICAL INSTRUMENTS, LLC 7305 HANCOCK VILLAGE DR SUITE 109 Chesterfield, VA 23832 |
Contact | Darren Reeves |
Correspondent | Darren Reeves MICROAIRE SURGICAL INSTRUMENTS, LLC 7305 HANCOCK VILLAGE DR SUITE 109 Chesterfield, VA 23832 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-24 |
Decision Date | 2012-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847399006615 | K113128 | 000 |
00847399006516 | K113128 | 000 |
00847399006523 | K113128 | 000 |
00847399006530 | K113128 | 000 |
00847399006547 | K113128 | 000 |
00847399006554 | K113128 | 000 |
00847399006561 | K113128 | 000 |
00847399006578 | K113128 | 000 |
00847399006592 | K113128 | 000 |
00847399006608 | K113128 | 000 |
00847399006417 | K113128 | 000 |