510(k) K843345
- Device
- Agl400 Argon Laser System-krl500 Krypton
- Applicant
- MIRA, INC.
- 510(k) number
- K843345
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-06
- Date received
- 1984-08-27
- Review panel
- Unknown
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK W FURLONG
- Address
- 87 Rumford Ave. Waltham MA US 02453 02453
Source Documents#
510(k) summary PDF not indicated by FDA