510(k) K852642
- Device
- CENTRAL VEIN CATHETERIZATION TRAY
- Applicant
- Teleflex Medical, Inc.
- 510(k) number
- K852642
- Product code
- FDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-01-16
- Date received
- 1985-06-21
- Regulation
- 876.1500
- Classification name
- Attachment, Eyepiece, For Insertion Of Prescription Lens
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HERBERT M CARTER
- Address
- Tall Pines Park Jeffrey NH US 03452 03452
FDA Registration Numbers#
- 3012322232
- 3010202439
- 3010041511
- 2020550
- 3011137372
- 3014342096
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FDZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K895772 | EXEL INDWELLING CATHETER | Exel Intl. | 1990-02-16 |
Legacy Summary#
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FDA Review#
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