SURGICAL SPEARS

Sponge, Ophthalmic

ULTRACELL MEDICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Ultracell Medical Technologies, Inc. with the FDA for Surgical Spears.

Pre-market Notification Details

Device IDK923922
510k NumberK923922
Device Name:SURGICAL SPEARS
ClassificationSponge, Ophthalmic
Applicant ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington,  CT  06359
ContactGeorge P Korteweg
CorrespondentGeorge P Korteweg
ULTRACELL MEDICAL TECHNOLOGIES, INC. P.O. BOX 326 North Stonington,  CT  06359
Product CodeHOZ  
CFR Regulation Number886.4790 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-05
Decision Date1993-03-19

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