The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Implantech Eptfe Sheeting, Model Eptfe-xxx.
| Device ID | K071470 |
| 510k Number | K071470 |
| Device Name: | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Contact | Stephen Meade |
| Correspondent | Stephen Meade IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-08-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724EPTFESHEET0611 | K071470 | 000 |
| M724EPTFESHEET0831 | K071470 | 000 |
| M724EPTFESHEET1011 | K071470 | 000 |
| M724EPTFESHEET0101 | K071470 | 000 |
| M724EPTFESHEET0131 | K071470 | 000 |
| M724EPTFESHEET0211 | K071470 | 000 |
| M724EPTFESHEET0221 | K071470 | 000 |
| M724EPTFESHEET0401 | K071470 | 000 |
| M724EPTFESHEET0411 | K071470 | 000 |
| M724EPTFESHEET0111 | K071470 | 000 |
| M724EPTFESHEET0121 | K071470 | 000 |
| M724EPTFESHEET0201 | K071470 | 000 |
| M724EPTFESHEET0231 | K071470 | 000 |
| M724EPTFESHEET0409061 | K071470 | 000 |
| M724EPTFESHEET0601 | K071470 | 000 |
| M724EPTFESHEET0631 | K071470 | 000 |