510(k) K841122
K841122 is an FDA 510(k) premarket notification submitted by Medcare Products for the device "TRACHEOSTOMY CARE TRAY". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Medcare Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1984
- Date Received
- March 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type