The following data is part of a premarket notification filed by Ellman Intl. Mfg., Inc. with the FDA for Surgitron Units- Electro Surg Syst Gyn Indication.
| Device ID | K914329 |
| 510k Number | K914329 |
| Device Name: | SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | ELLMAN INTL. MFG., INC. C/O NO. AMER TECH SERV CORP. 407 EAST MAIN ST., PO BOX 347 Port Jefferson, NY 11777 |
| Contact | Richard Lanzillotto |
| Correspondent | Richard Lanzillotto ELLMAN INTL. MFG., INC. C/O NO. AMER TECH SERV CORP. 407 EAST MAIN ST., PO BOX 347 Port Jefferson, NY 11777 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-27 |
| Decision Date | 1992-04-02 |