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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K923175
Device Name SURGICAL INSTRUMENT KIT, DISPOSABLE
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 Number880.6250
Classification Product Code
FMC  
Date Received06/12/1992
Decision Date 06/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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