The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for 3d Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar Ii Implant, Dorsal Columella Imp.
| Device ID | K141027 |
| 510k Number | K141027 |
| Device Name: | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP |
| Classification | Prosthesis, Chin, Internal |
| 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 | FWP |
| Subsequent Product Code | FZE |
| Subsequent Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-22 |
| Decision Date | 2014-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724ESPNSIZNS1 | K141027 | 000 |
| M724ESNPS231 | K141027 | 000 |
| M724ESNPL351 | K141027 | 000 |
| M724ESNPL231 | K141027 | 000 |
| M724ESMFSIZNS1 | K141027 | 000 |
| M724ESMFS1 | K141027 | 000 |
| M724ESMFM1 | K141027 | 000 |
| M724ESMFL1 | K141027 | 000 |
| M724ESFHSIZNS1 | K141027 | 000 |
| M724ESFHS1 | K141027 | 000 |
| M724ESFHM1 | K141027 | 000 |
| M724ESFHL1 | K141027 | 000 |
| M724ESECSIZNS1 | K141027 | 000 |
| M724ESECM1 | K141027 | 000 |
| M724ESECL1 | K141027 | 000 |
| M724EPTFESHEET055B1 | K141027 | 000 |
| M724ESNPS351 | K141027 | 000 |
| M724ESNPSIZNS1 | K141027 | 000 |
| M724ESPNS61 | K141027 | 000 |
| M724ESPNS51 | K141027 | 000 |
| M724ESPNM61 | K141027 | 000 |
| M724ESPNM51 | K141027 | 000 |
| M724ESPNL61 | K141027 | 000 |
| M724ESPNL51 | K141027 | 000 |
| M724ESPMSIZNS1 | K141027 | 000 |
| M724ESPMS1 | K141027 | 000 |
| M724ESPMM1 | K141027 | 000 |
| M724ESPML1 | K141027 | 000 |
| M724ESNRSIZNS1 | K141027 | 000 |
| M724ESNRS351 | K141027 | 000 |
| M724ESNRS231 | K141027 | 000 |
| M724ESNRL351 | K141027 | 000 |
| M724ESNRL231 | K141027 | 000 |
| M724EPTFESHEET045B1 | K141027 | 000 |