The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Adiprep Adipose Transfer System.
| Device ID | K121005 |
| 510k Number | K121005 |
| Device Name: | ADIPREP ADIPOSE TRANSFER SYSTEM |
| Classification | System, Suction, Lipoplasty |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583514966 | K121005 | 000 |
| 05020583514331 | K121005 | 000 |
| 05020583514348 | K121005 | 000 |
| 05020583514317 | K121005 | 000 |
| 05020583514355 | K121005 | 000 |
| 35020583514318 | K121005 | 000 |
| 35020583514325 | K121005 | 000 |
| 35020583514332 | K121005 | 000 |
| 35020583514349 | K121005 | 000 |
| 35020583514356 | K121005 | 000 |
| 05020583514324 | K121005 | 000 |