510(k) K992649

ATD AUTOMATIC BRIDGE REMOVER by J. Morita USA, Inc. — Product Code EIS

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