510(k) K990979
K990979 is an FDA 510(k) premarket notification submitted by Steco-System-Technik GmbH & Cokg for the device "STECO-TITANMAGNETICS". The FDA issued a decision of Substantially Equivalent on September 3, 1999. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1999
- Date Received
- March 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Attachment, Precision, All
- Device Class
- Class I
- Regulation Number
- 872.3165
- Review Panel
- DE
- Submission Type