510(k) K894045
K894045 is an FDA 510(k) premarket notification submitted by Devetec, Inc. for the device "MODIFIED POLYCHROME IV STAIN". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code KFD (Aniline Blue), a Class I device regulated under 21 CFR 864.1850. Devetec, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1989
- Date Received
- June 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aniline Blue
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type