The following data is part of a premarket notification filed by Ellman Int'l Inc. with the FDA for Ellman International Non-ablative Technique For Surgitron Iec.
Device ID | K082834 |
510k Number | K082834 |
Device Name: | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ELLMAN INT'L INC. 3333 ROYAL AVENUE Oceanside, NY 11572 -3625 |
Contact | Rick Epstein |
Correspondent | Rick Epstein 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 | 2008-09-26 |
Decision Date | 2009-05-07 |
Summary: | summary |