510(k) K934815
K934815 is an FDA 510(k) premarket notification submitted by Defiance Electronics, Inc. for the device "AIR COMPRESSOR, MODEL PAC 6.7". The FDA issued a decision of Substantially Equivalent on February 1, 1994. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Defiance Electronics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1994
- Date Received
- October 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type