The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron Iec Ii.
Device ID | K001986 |
510k Number | K001986 |
Device Name: | SURGITRON IEC II |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
Contact | Frank Lin |
Correspondent | Frank Lin ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-29 |
Decision Date | 2000-09-27 |