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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K950370
Device Name ULTRACELL ORTHOPEDIC SPONGES
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Applicant Contact GEORGE P KORTEWEG
Correspondent
ULTRACELL MEDICAL TECHNOLOGIES, INC.
POST OFFICE BOX 609
OLD MYSTIC,  CT  06372
Correspondent Contact GEORGE P KORTEWEG
Regulation Number878.4450
Classification Product Code
GDY  
Date Received01/31/1995
Decision Date 04/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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