The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Pal Multi-use Cannulas And Pal Manual Wand.
Device ID | K171286 |
510k Number | K171286 |
Device Name: | PAL Multi-Use Cannulas And PAL Manual Wand |
Classification | System, Suction, Lipoplasty |
Applicant | MicroAire Surgical Instruments, LLC 3590 Grans Forks Blvd Charlottesville, VA 22911 |
Contact | Glenn Gerstenfeld |
Correspondent | Diane Sudduth BARILE & ASSOCIATES, INC P.O. Box 5199 Clinton, NJ 08809 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-01 |
Decision Date | 2017-10-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847399008800 | K171286 | 000 |
00847399008992 | K171286 | 000 |
00847399009005 | K171286 | 000 |
00847399009098 | K171286 | 000 |
00847399009104 | K171286 | 000 |
00847399009111 | K171286 | 000 |
00847399009128 | K171286 | 000 |
00847399009135 | K171286 | 000 |
00847399009142 | K171286 | 000 |
00847399008985 | K171286 | 000 |
00847399008954 | K171286 | 000 |
00847399008879 | K171286 | 000 |
00847399008886 | K171286 | 000 |
00847399008893 | K171286 | 000 |
00847399008909 | K171286 | 000 |
00847399008916 | K171286 | 000 |
00847399008923 | K171286 | 000 |
00847399008930 | K171286 | 000 |
00847399008947 | K171286 | 000 |
00847399009159 | K171286 | 000 |
00847399009166 | K171286 | 000 |
00847399009173 | K171286 | 000 |
00847399009289 | K171286 | 000 |
00847399009296 | K171286 | 000 |
00847399009302 | K171286 | 000 |
00847399009333 | K171286 | 000 |
00847399009340 | K171286 | 000 |
00847399015716 | K171286 | 000 |
00847399015723 | K171286 | 000 |
00847399015730 | K171286 | 000 |
00847399009272 | K171286 | 000 |
00847399009265 | K171286 | 000 |
00847399009180 | K171286 | 000 |
00847399009197 | K171286 | 000 |
00847399009203 | K171286 | 000 |
00847399009210 | K171286 | 000 |
00847399009227 | K171286 | 000 |
00847399009234 | K171286 | 000 |
00847399009241 | K171286 | 000 |
00847399009258 | K171286 | 000 |
00847399015747 | K171286 | 000 |