MEDI-FRIG

Unit, Cryosurgical, Accessories

ELLMAN INTL., INC.

The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Medi-frig.

Pre-market Notification Details

Device IDK954703
510k NumberK954703
Device Name:MEDI-FRIG
ClassificationUnit, Cryosurgical, Accessories
Applicant ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
ContactRichard C Lanzillotto
CorrespondentRichard C Lanzillotto
ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach,  NY  11789 -1734
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-12
Decision Date1996-02-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494103866 K954703 000
00841494103224 K954703 000
10841494105133 K954703 000

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