510(k) K023125
- Device
- COALESCENT U-CLIP- AND ACCESSORIES
- Applicant
- COALESCENT SURGICAL
- 510(k) number
- K023125
- Product code
- NJU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-18
- Date received
- 2002-09-19
- Regulation
- 878.4495
- Classification name
- Suture, Nonabsorbable, Nitinol
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL A DANIEL
- Address
- 559 E. Weddell Dr. Sunnyvale CA US 94089 94089
Source Documents#
Other 510(k) Records For Product Code NJU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023372 | NON-BIOABSORBABLE STAPLE | Onux Medical, Inc. | 2002-12-27 |
Legacy Summary#
summary
FDA Review#
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