OPPORTUNITY INC. GENERAL PURPOSE TRAY
FDA 510(k) clearance K971062 · decided 1997-06-09
Clearance details
- K-number
- K971062
- Device name
- OPPORTUNITY INC. GENERAL PURPOSE TRAY
- Applicant
- Opportunity, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-03-24
- Decision date
- 1997-06-09
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LRO
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Highland Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.