NULIFE
FDA 510(k) clearance K962837 · decided 1996-10-02
Clearance details
- K-number
- K962837
- Device name
- NULIFE
- Applicant
- Med-Tech Rubber & Engineering Industries
- Decision
- Substantially Equivalent
- Date received
- 1996-07-09
- Decision date
- 1996-10-02
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sussex Rad, Yculla,, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.