The following data is part of a premarket notification filed by Dio-med Corp. with the FDA for Diomed 25 25w Surgical Diode Laser.
Device ID | K931776 |
510k Number | K931776 |
Device Name: | DIOMED 25 25W SURGICAL DIODE LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | DIO-MED CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Toby Johnston |
Correspondent | Toby Johnston DIO-MED CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-09 |
Decision Date | 1993-10-19 |