The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron 120 Iec (also Known As Surgitron 4.0 Dual Rf.
Device ID | K013255 |
510k Number | K013255 |
Device Name: | SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF |
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 | 2001-09-28 |
Decision Date | 2001-11-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494108465 | K013255 | 000 |
00841494108472 | K013255 | 000 |
00841494106690 | K013255 | 000 |
00841494104887 | K013255 | 000 |
00841494104870 | K013255 | 000 |