ULTRACELL ORTHOPEDIC SPONGES

Gauze/sponge, Internal, X-ray Detectable

ULTRACELL MEDICAL TECHNOLOGIES, INC.

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

Pre-market Notification Details

Device IDK950372
510k NumberK950372
Device Name:ULTRACELL ORTHOPEDIC SPONGES
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic,  CT  06372
ContactGeorge P Korteweg
CorrespondentGeorge P Korteweg
ULTRACELL MEDICAL TECHNOLOGIES, INC. POST OFFICE BOX 609 Old Mystic,  CT  06372
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-31
Decision Date1995-04-17

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