COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
FDA 510(k) clearance K013243 · decided 2002-01-09
Clearance details
- K-number
- K013243
- Device name
- COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
- Applicant
- Bioform, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-28
- Decision date
- 2002-01-09
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- KHJ
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Franksville, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Imp recall (Z-0368-2016) | Merz North America, Inc. | 2015-12-03 |