510(k) K955282
K955282 is an FDA 510(k) premarket notification submitted by Thermogenesis Corp. for the device "THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS". The FDA issued a decision of Substantially Equivalent on May 6, 1996. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Thermogenesis Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1996
- Date Received
- November 16, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type