510(k) K841589
K841589 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "C-LITE". The FDA issued a decision of Substantially Equivalent on May 22, 1984. The device falls under product code KYT (Light, Examination, Medical, Battery Powered), a Class I device regulated under 21 CFR 880.6350. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 1984
- Date Received
- April 18, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Examination, Medical, Battery Powered
- Device Class
- Class I
- Regulation Number
- 880.6350
- Review Panel
- HO
- Submission Type