PPMI-(XXX) AND PPMO-(XXX)
FDA 510(k) clearance K953231 · decided 1995-09-07
Clearance details
- K-number
- K953231
- Device name
- PPMI-(XXX) AND PPMO-(XXX)
- Applicant
- Patriot Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-10
- Decision date
- 1995-09-07
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Owosso, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.