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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K914244
Device Name STERILE CUSTOM SURGICAL KITS
Applicant
Ulti-Med Intl., Inc.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Applicant Contact DAVID INSCO
Correspondent
Ulti-Med Intl., Inc.
1688 Glen Ellyn Rd.
Glendale Hts.,  IL  60139
Correspondent Contact DAVID INSCO
Regulation Number878.4800
Classification Product Code
KDD  
Date Received09/23/1991
Decision Date 02/24/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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