510(k) K853463
K853463 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "LX EMBEDDING CENTER". The FDA issued a decision of Substantially Equivalent on August 28, 1985. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1985
- Date Received
- August 19, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No