The following data is part of a premarket notification filed by Bioform, Inc. with the FDA for Coaptite Laryngeal Augmentation System 1cc & O.5cc, Models 0008021-1, 0008022-1.
| Device ID | K013243 |
| 510k Number | K013243 |
| Device Name: | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Contact | Victor M Bowers |
| Correspondent | Victor M Bowers BIOFORM, INC. 4133 COURTNEY ROAD, #10 Franksville, WI 53126 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-28 |
| Decision Date | 2002-01-09 |
| Summary: | summary |