The following data is part of a premarket notification filed by Accutech Medical Technologies, Inc. with the FDA for Accutech Family Of Powerflex Laser Delivery Devices.
| Device ID | K090281 |
| 510k Number | K090281 |
| Device Name: | ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-05 |
| Decision Date | 2009-03-04 |
| Summary: | summary |