The following data is part of a premarket notification filed by Ellman International, Inc. with the FDA for Pelleve Glidesafe 10mm, 15mm & 20mm Handpiece, Pelleve S5 - Iec.
| Device ID | K132665 |
| 510k Number | K132665 |
| Device Name: | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELLMAN INTERNATIONAL, INC. 400 KARIN LANE Hicksville, NY 11801 |
| Contact | Alison Sathe |
| Correspondent | Alison Sathe ELLMAN INTERNATIONAL, INC. 400 KARIN LANE Hicksville, NY 11801 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-27 |
| Decision Date | 2013-09-25 |
| Summary: | summary |