NIIC CO2 LASER SYSTEM MODEL 3OZ.
FDA 510(k) clearance K827914 · decided 1982-09-13
Clearance details
- K-number
- K827914
- Device name
- NIIC CO2 LASER SYSTEM MODEL 3OZ.
- Applicant
- Cooper Lasersonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-13
- Decision date
- 1982-09-13
- Days to decision
- 31 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.