The following data is part of a premarket notification filed by Continuum Biomedical, Inc. with the FDA for Scanning Device Accessory For Use With The Cb Erbium/2.94 Er:yag Laser.
Device ID | K971879 |
510k Number | K971879 |
Device Name: | SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 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 | 1997-05-21 |
Decision Date | 1997-08-14 |
Summary: | summary |