510(k) K844364
K844364 is an FDA 510(k) premarket notification submitted by Luneau Laboratories for the device "SKIASCOPIC RACKS". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code HMH (Rack, Skiascopic), a Class I device regulated under 21 CFR 886.1750. Luneau Laboratories has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1985
- Date Received
- November 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rack, Skiascopic
- Device Class
- Class I
- Regulation Number
- 886.1750
- Review Panel
- OP
- Submission Type