510(k) K051077
K051077 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101". The FDA issued a decision of Substantially Equivalent on May 3, 2005. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Aseptico, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2005
- Date Received
- April 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type