510(k) K896586
K896586 is an FDA 510(k) premarket notification submitted by Percussionaire Corp. for the device "RATE INCREASE FOR IPPB/IPV". The FDA issued a decision of Substantially Equivalent on January 9, 1990. The device falls under product code DZD (Tube, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Percussionaire Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1990
- Date Received
- November 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5410
- Review Panel
- DE
- Submission Type