510(k) K891754
- Device
- DC-4 SHUNT INFUSION T
- Applicant
- AKCESS MEDICAL PRODUCTS, INC.
- 510(k) number
- K891754
- Product code
- FKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-07
- Date received
- 1989-03-23
- Regulation
- 876.5820
- Classification name
- Connector, Blood Tubing, Infusion T
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD J HOPKINS
- Address
- 789 Jersey Ave. New Brunswick NJ US 08901 08901
FDA Registration Numbers#
- 2011171
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771426 | PEDIATRIC INFUSION T | Quinton, Inc. | 1977-12-20 |
Legacy Summary#
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FDA Review#
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