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 |