The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Cb Erbium/2.94(tm) Er:yag Laser.
| Device ID | K970934 |
| 510k Number | K970934 |
| Device Name: | CB ERBIUM/2.94(TM) ER:YAG LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin, CA 94568 |
| Contact | Robert S Anderson |
| Correspondent | Robert S Anderson CONTINUUM BIOMEDICAL, INC. 6533 SIERRA LN. Dublin, CA 94568 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-13 |
| Decision Date | 1997-06-11 |
| Summary: | summary |