FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MODEL ML-850
K Number: K827963
·
Decision Sep 13, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODEL ML-850
- K Number
- K827963
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Merrimack Laboratories
- Date Received
- August 20, 1982
- Decision Date
- September 13, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Merrimack Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K833528 | CARBON DIOXIDE LASER ML 825 | Feb 19, 1985 | Substantially Equivalent |
| K833483 | ENDOSCOPIC COUPLER | Feb 10, 1984 | Substantially Equivalent |
| K827506 | MODEL ML-820 CARBON DIOXIDE LASER SYSTEM FOR SURGERY | Jun 11, 1982 | Substantially Equivalent |
| K827442 | ML-810 CARBON DIOXIDE LASER SYSTEM | May 19, 1982 | Substantially Equivalent |
| K800227 | ML-800 CO2 | Mar 3, 1980 | Substantially Equivalent |