The following data is part of a premarket notification filed by Aseptico, Inc. with the FDA for Ahp-66 4:1 Reduction Contrangle: Ahp-88 8:1 Reduction Contrangle: Ahp-88mp 8:1 Reduction Contrangle - Push Button.
| Device ID | K020137 |
| 510k Number | K020137 |
| Device Name: | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Contact | Grant Ramaley |
| Correspondent | Grant Ramaley ASEPTICO, INC. 8333 216TH ST., S.E. Woodinville, WA 98072 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-16 |
| Decision Date | 2002-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023438 | K020137 | 000 |