The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Tissu Trans Filtron Syringe Fill.
| Device ID | K102117 |
| 510k Number | K102117 |
| Device Name: | TISSU TRANS FILTRON SYRINGE FILL |
| Classification | System, Suction, Lipoplasty |
| Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 6248 SOUTH TROY CIRCLE UNIT A Centennial, CO 80111 |
| Contact | Sarah Lake Shippert |
| Correspondent | Sarah Lake 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-28 |
| Decision Date | 2010-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00893398002363 | K102117 | 000 |
| 00893398002349 | K102117 | 000 |
| 00893398002332 | K102117 | 000 |
| 00893398002318 | K102117 | 000 |
| 00893398002295 | K102117 | 000 |
| 00893398002288 | K102117 | 000 |
| 00893398002233 | K102117 | 000 |