PHILLY INFANT BOLT
FDA 510(k) clearance K820151 · decided 1982-01-28
Clearance details
- K-number
- K820151
- Device name
- PHILLY INFANT BOLT
- Applicant
- Philadelphia Medical Specialties
- Decision
- Substantially Equivalent
- Date received
- 1982-01-19
- Decision date
- 1982-01-28
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- GWN
- Device class
- 2
- Regulation number
- 882.1460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.