AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
FDA 510(k) clearance K843345 · decided 1984-11-06
Clearance details
- K-number
- K843345
- Device name
- AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON
- Applicant
- Mira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-27
- Decision date
- 1984-11-06
- Days to decision
- 71 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.