The following data is part of a premarket notification filed by Accutech Medical Technologies, Inc. with the FDA for Accutech Endolite Probe.
| Device ID | K061025 |
| 510k Number | K061025 |
| Device Name: | ACCUTECH ENDOLITE PROBE |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | ACCUTECH MEDICAL TECHNOLOGIES, INC. 3637 BERNAL AVE Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden ACCUTECH MEDICAL TECHNOLOGIES, INC. 3637 BERNAL AVE Pleasanton, CA 94566 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-05-31 |
| Summary: | summary |