The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Flowers Jowl Implant.
| Device ID | K905268 |
| 510k Number | K905268 |
| Device Name: | FLOWERS JOWL IMPLANT |
| Classification | Prosthesis, Chin, Internal |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | FWP |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-21 |
| Decision Date | 1991-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724TMA4L101 | K905268 | 000 |
| M724TMA08R1 | K905268 | 000 |
| M724VMA11L1 | K905268 | 000 |
| M724VMA11R1 | K905268 | 000 |
| M724VMA13L1 | K905268 | 000 |
| M724VMA13R1 | K905268 | 000 |
| M724VMA7L1 | K905268 | 000 |
| M724VMA7R1 | K905268 | 000 |
| M724CMA10R1 | K905268 | 000 |
| M724CMA12L1 | K905268 | 000 |
| M724CMA12R1 | K905268 | 000 |
| M724FMGVL1 | K905268 | 000 |
| M724CMA10L1 | K905268 | 000 |
| M724TMA4L121 | K905268 | 000 |
| M724TMA4L81 | K905268 | 000 |
| M724TMA4R1 | K905268 | 000 |
| M724TMA4R101 | K905268 | 000 |
| M724TMA4R121 | K905268 | 000 |
| M724TMA4R81 | K905268 | 000 |
| M724TMA6L1 | K905268 | 000 |
| M724TMA6R1 | K905268 | 000 |
| M724TMA8L1 | K905268 | 000 |
| M724TMA8R1 | K905268 | 000 |
| M724CMA14L1 | K905268 | 000 |
| M724CMA14R1 | K905268 | 000 |
| M724CMA8L1 | K905268 | 000 |
| M724TMA04R1 | K905268 | 000 |
| M724TMA06L1 | K905268 | 000 |
| M724TMA06R1 | K905268 | 000 |
| M724TMA08L1 | K905268 | 000 |
| M724TMA10L1 | K905268 | 000 |
| M724TMA10R1 | K905268 | 000 |
| M724WMA10R1 | K905268 | 000 |
| M724WMA5L1 | K905268 | 000 |
| M724WMA5R1 | K905268 | 000 |
| M724WMA7L1 | K905268 | 000 |
| M724TMA04L1 | K905268 | 000 |
| M724TMA0412R1 | K905268 | 000 |
| M724CMA8R1 | K905268 | 000 |
| M724FMGVM1 | K905268 | 000 |
| M724FMGVS1 | K905268 | 000 |
| M724FMGVXL1 | K905268 | 000 |
| M724FMGVXS1 | K905268 | 000 |
| M724TMA0408L1 | K905268 | 000 |
| M724TMA0408R1 | K905268 | 000 |
| M724TMA0410L1 | K905268 | 000 |
| M724TMA0410R1 | K905268 | 000 |
| M724TMA0412L1 | K905268 | 000 |
| M724WMA7R1 | K905268 | 000 |