The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for Ellman Laptrode.
| Device ID | K953440 |
| 510k Number | K953440 |
| Device Name: | ELLMAN LAPTRODE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-12 |
| Decision Date | 1995-08-29 |