510(k) K122263
- Device
- 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE
- Applicant
- SYMMETRY MEDICAL
- 510(k) number
- K122263
- Product code
- ODY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-09-28
- Date received
- 2012-07-27
- Regulation
- 880.5970
- Classification name
- Tunneled Catheter Remover
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HANNAH FOLEY
- Address
- 3034 Owen Dr. Antioch TN US 37013 37013
FDA Registration Numbers#
- 1123137
- 1061124
- 3015225571
- 3012536737
- 1125782
- 3015309643
- 1721504
- 3033589330
- 3006950086
Source Documents#
Other 510(k) Records For Product Code ODY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K063048 | TRANS-CATHETER EXTRACTOR | Tran Pa-C, Inc. | 2007-09-14 |
Legacy Summary#
summary
FDA Review#
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