510(k) K063245
- Device
- ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
- Applicant
- BACTERIN INTERNATIONAL INC.
- 510(k) number
- K063245
- Product code
- OEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-28
- Date received
- 2006-10-26
- Regulation
- 878.4780
- Classification name
- Drainage Catheter With Antibiotic
- 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
- JOSEPH M AZARY
- Address
- 543 Long Hill Ave. Shelton CT US 06484 06484
Source Documents#
Legacy Summary#
summary
FDA Review#
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