Substantially Equivalent 510(k) Device Information
Applicant: DENCO, Inc. Wilmington, DE
510(k) number: BK000022
Product: Total Containment Device
Date: 4/18/2000
Summary of Safety and Effectiveness
This Summary was prepared in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92
GENERAL INFORMATION
| Device Name: |
Total Containment Device
Model B - 50 |
| Classification Name: |
None |
PERFORMANCE STANDARDS
No mandatory standards have been established
INDICATION FOR USE
This medical device is substantially equivalent to our currently
marketed TCD Model B-40.
TECHNOLOGICAL CHARATERISTICS
Our Marketed TCD Model B-40 is designed to make sterile
connections with nominally sized 4.3 mm OD tubing.
This modification provides for a different clamp or Taper Lock
to accommodate up to nominally sized 5.4 mm OD tubing.
|
