The following data is part of a premarket notification filed by Bioform Medical, Inc. with the FDA for Radiesse Laryngeal Implant.
Device ID | K070090 |
510k Number | K070090 |
Device Name: | RADIESSE LARYNGEAL IMPLANT |
Classification | System, Vocal Cord Medialization |
Applicant | BIOFORM MEDICAL, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo, CA 94402 |
Contact | James Miller |
Correspondent | James 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 | 2007-01-10 |
Decision Date | 2007-03-01 |
Summary: | summary |