510(k) K840373
K840373 is an FDA 510(k) premarket notification submitted by Suncoast Medical Manufacturers, Inc. for the device "FLEXIBLE ILLUMINATOR 10". The FDA issued a decision of Substantially Equivalent on April 24, 1984. The device falls under product code FTF (Illuminator, Non-Remote), a Class II device regulated under 21 CFR 878.4580. Suncoast Medical Manufacturers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 1984
- Date Received
- January 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Illuminator, Non-Remote
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type