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 |