Model ML-850
FDA 510(k) K827963 · Merrimack Laboratories
510(k) numberK827963
Submission
- Device name
- Model ML-850
- Applicant
- Merrimack Laboratories
Hudson, MA, US - Received
- August 20, 1982
- Decision date
- September 13, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Merrimack Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K833528 | Carbon Dioxide Laser ML 825HHR · Traditional | 02/19/1985SE |
| K833483 | Endoscopic CouplerEOQ · Traditional | 02/10/1984SE |
| K827506 | Model ML-820 Carbon Dioxide Laser System for Surgery · Traditional | 06/11/1982SE |
| K827442 | ML-810 Carbon Dioxide Laser System · Traditional | 05/19/1982SE |
| K800227 | ML-800 CO2HHR · Traditional | 03/03/1980SE |
Questions and answers
When was Model ML-850 cleared by the FDA?
Model ML-850 (K827963) received a 510(k) decision of Substantially Equivalent on September 13, 1982, 24 days after the submission was received.