510(k) K020137
K020137 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON". The FDA issued a decision of Substantially Equivalent on March 4, 2002. 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
- March 4, 2002
- Date Received
- January 16, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type