510(k) K013243
K013243 is an FDA 510(k) premarket notification submitted by Bioform, Inc. for the device "COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1". The FDA issued a decision of Substantially Equivalent on January 9, 2002. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Bioform, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2002
- Date Received
- September 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- EN
- Submission Type