The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Tissu Trans Filtron, Models 3-tt-filtron 2000-500.
Device ID | K092482 |
510k Number | K092482 |
Device Name: | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 |
Classification | System, Suction, Lipoplasty |
Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
Contact | Sarah L Shippert |
Correspondent | Sarah L Shippert SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-13 |
Decision Date | 2009-12-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00893398002271 | K092482 | 000 |
00385640084994 | K092482 | 000 |
00385640085007 | K092482 | 000 |
00385640085014 | K092482 | 000 |
00385640085021 | K092482 | 000 |
00385640053747 | K092482 | 000 |
00385640053754 | K092482 | 000 |
00385640053761 | K092482 | 000 |
00385640053778 | K092482 | 000 |
00385640053785 | K092482 | 000 |
00385640053792 | K092482 | 000 |
00893398002165 | K092482 | 000 |
00893398002172 | K092482 | 000 |
00893398002240 | K092482 | 000 |
00893398002257 | K092482 | 000 |
00893398002264 | K092482 | 000 |
00385640084987 | K092482 | 000 |