510(k) K870599
K870599 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "TIP, DENTAL SUCTION APPARATUS". The FDA issued a decision of Substantially Equivalent on March 23, 1987. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1987
- Date Received
- February 10, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthpiece, Saliva Ejector
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type