510(k) K032078
- Device
- MITEK MICRO QUICKANCHOR
- Applicant
- MITEK WORLDWIDE
- 510(k) number
- K032078
- Product code
- NOV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-25
- Date received
- 2003-07-07
- Regulation
- 888.3030
- Classification name
- Anchor, Suture, Bone Fixation, Metallic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SERGIO J GADALETA
- Address
- A Johnson & Johnson Company 249 Vanderbilt Ave. Norwood MA US 02062 02062
FDA Registration Numbers#
- 3008868758
- 1221934
Source Documents#
Legacy Summary#
summary
FDA Review#
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