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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 K950659
Device Name ULTRACELL RETRACTOR COVERS
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 Received02/13/1995
Decision Date 04/13/1995
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
Predetermined Change
Control Plan Authorized		 No
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