510(k) K873002
K873002 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "MIN-IDENTOFLEX". The FDA issued a decision of Substantially Equivalent on August 17, 1987. The device falls under product code EHJ (Disk, Abrasive), a Class I device regulated under 21 CFR 872.6010. Centrix, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1987
- Date Received
- August 4, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Disk, Abrasive
- Device Class
- Class I
- Regulation Number
- 872.6010
- Review Panel
- DE
- Submission Type