The following data is part of a premarket notification filed by Gfe Medizintechnik Gmbh with the FDA for Timesh Also Known As Timesh-tc, Models 6000001 & 6000004.
| Device ID | K031225 |
| 510k Number | K031225 |
| Device Name: | TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | GFE MEDIZINTECHNIK GMBH 6254 SOUTH 1280 EAST Salt Lake City, UT 84121 |
| Contact | John E Sawyer |
| Correspondent | John E Sawyer GFE MEDIZINTECHNIK GMBH 6254 SOUTH 1280 EAST Salt Lake City, UT 84121 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042301144348 | K031225 | 000 |
| 04042301097576 | K031225 | 000 |
| 04042301097590 | K031225 | 000 |
| 04042301097606 | K031225 | 000 |
| 04042301097637 | K031225 | 000 |
| 04042301097651 | K031225 | 000 |
| 04042301097668 | K031225 | 000 |
| 04042301102775 | K031225 | 000 |
| 04042301137173 | K031225 | 000 |
| 04042301117793 | K031225 | 000 |
| 04042301117809 | K031225 | 000 |
| 04042301144324 | K031225 | 000 |
| 04042301097552 | K031225 | 000 |