The following data is part of a premarket notification filed by Microaire Surgical Instruments, Llc with the FDA for Pal System.
Device ID | K212024 |
510k Number | K212024 |
Device Name: | PAL System |
Classification | System, Suction, Lipoplasty |
Applicant | MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd Charlottesville, VA 22911 |
Contact | Glenn Gerstenfeld |
Correspondent | Glenn Gerstenfeld MicroAire Surgical Instruments, LLC 3590 Grand Forks Blvd 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 | 2021-06-29 |
Decision Date | 2022-06-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847399016898 | K212024 | 000 |
00847399016874 | K212024 | 000 |
00847399008725 | K212024 | 000 |
00847399006646 | K212024 | 000 |
00847399003829 | K212024 | 000 |
00847399003812 | K212024 | 000 |
00847399018410 | K212024 | 000 |
00847399018373 | K212024 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PAL SYSTEM 79276284 not registered Live/Pending |
ERSAS ALÃMINYUM ANONIM SIRKETI 2019-11-04 |
PAL SYSTEM 75664685 2470275 Dead/Cancelled |
Ranpak Corp. 1999-03-22 |
PAL SYSTEM 73560686 1424569 Dead/Cancelled |
WESTWAY PRODUCTS CORP 1985-09-30 |
PAL SYSTEM 73507228 not registered Dead/Abandoned |
SIMPLY MARKETING, INC. 1984-11-05 |