510(k) K992649
K992649 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "ATD AUTOMATIC BRIDGE REMOVER". The FDA issued a decision of Substantially Equivalent on October 29, 1999. The device falls under product code EIS (Remover, Crown), a Class I device regulated under 21 CFR 872.4565. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1999
- Date Received
- August 6, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Remover, Crown
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type