The following data is part of a premarket notification filed by Bioform Medical, Inc. with the FDA for Juliesse Injectable Laryngeal Augmentation Implant.
| Device ID | K060815 |
| 510k Number | K060815 |
| Device Name: | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT |
| Classification | System, Vocal Cord Medialization |
| Applicant | BIOFORM MEDICAL, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo, CA 94402 |
| Contact | James S Miller |
| Correspondent | James S Miller BIOFORM MEDICAL, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo, CA 94402 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-04-18 |
| Summary: | summary |