510(k) K050957
K050957 is an FDA 510(k) premarket notification submitted by Special Devices, Inc. for the device "EUTROCHAR". The FDA issued a decision of Substantially Equivalent on May 18, 2005. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), a Class I device regulated under 21 CFR 878.4800. Special Devices, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2005
- Date Received
- April 15, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type