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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 K920356
Device Name SURGICAL SPONGES
Applicant
Ultracell Medical Technologies, Inc.
P.O. Box 326
North Stonington,  CT  06359
Applicant Contact GEORGE P KORTEWEG
Correspondent
Ultracell Medical Technologies, Inc.
P.O. Box 326
North Stonington,  CT  06359
Correspondent Contact GEORGE P KORTEWEG
Regulation Number878.4450
Classification Product Code
GDY  
Date Received01/27/1992
Decision Date 08/06/1992
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
Predetermined Change
Control Plan Authorized		 No
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