SUTTER PHALANGEAL CAP
FDA 510(k) clearance K875249 · decided 1988-02-03
Clearance details
- K-number
- K875249
- Device name
- SUTTER PHALANGEAL CAP
- Applicant
- Sutter Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-22
- Decision date
- 1988-02-03
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KWD
- Device class
- 2
- Regulation number
- 888.3730
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.