The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Surgitron Radiolase Ii.
Device ID | K042710 |
510k Number | K042710 |
Device Name: | SURGITRON RADIOLASE II |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
Contact | Frank Lin |
Correspondent | Frank Lin ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-30 |
Decision Date | 2005-04-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494104351 | K042710 | 000 |
00841494101794 | K042710 | 000 |
00841494101787 | K042710 | 000 |