The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Medlite C Series Compression Tool And Handpiece Attachment Accessory, Model 659-0523.
| Device ID | K060977 |
| 510k Number | K060977 |
| Device Name: | MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOYA CONBIO, INC 47733 FREMONT BLVD Fremont, CA 94538 |
| Contact | Jim Green |
| Correspondent | Jim Green HOYA CONBIO, INC 47733 FREMONT BLVD Fremont, CA 94538 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-05-24 |
| Summary: | summary |