BLAKEMORE RETAINER
FDA 510(k) clearance K880253 · decided 1988-03-11
Clearance details
- K-number
- K880253
- Device name
- BLAKEMORE RETAINER
- Applicant
- Orthopedic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-20
- Decision date
- 1988-03-11
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- FEF
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hayward, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.