SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION

Electrocautery, Gynecologic (and Accessories)

ELLMAN INTL. MFG., INC.

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.

Pre-market Notification Details

Device IDK914329
510k NumberK914329
Device Name:SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION
ClassificationElectrocautery, 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
ContactRichard Lanzillotto
CorrespondentRichard Lanzillotto
ELLMAN INTL. MFG., INC. C/O NO. AMER TECH SERV CORP. 407 EAST MAIN ST., PO BOX 347 Port Jefferson,  NY  11777
Product CodeHGI  
CFR Regulation Number884.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-27
Decision Date1992-04-02

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