The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Staple Line Reinforcement.
Device ID | K170945 |
510k Number | K170945 |
Device Name: | Biodesign Staple Line Reinforcement |
Classification | Mesh, Surgical, Collagen, Staple Line Reinforcement |
Applicant | Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
Contact | Perry W. Guinn |
Correspondent | Daniela I. Changkuon Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 |
Product Code | OXE |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-30 |
Decision Date | 2017-04-28 |
Summary: | summary |