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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K904896
Device Name EYE PAD
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 Number878.4440
Classification Product Code
HMP  
Date Received10/30/1990
Decision Date 12/05/1990
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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