The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Anastomosis Visualization Device.
Device ID | K974568 |
510k Number | K974568 |
Device Name: | CHASE ANASTOMOSIS VISUALIZATION DEVICE |
Classification | Lavage, Jet |
Applicant | CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
Contact | Bert Davis |
Correspondent | Bert Davis CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
Product Code | FQH |
CFR Regulation Number | 880.5475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-12-05 |
Decision Date | 1998-01-06 |
Summary: | summary |