510(k) K870590
K870590 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY". The FDA issued a decision of Substantially Equivalent on April 16, 1987. The device falls under product code EMS (Curette, Periodontic), a Class I device regulated under 21 CFR 872.4565. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1987
- Date Received
- February 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Curette, Periodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type