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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K933041
Device Name COLD CD ASP MODULE, ITE
Applicant
Electone, Inc.
1124 Florida Central Pkwy.
Longwood,  FL  32750
Applicant Contact JIM NEE
Correspondent
Electone, Inc.
1124 Florida Central Pkwy.
Longwood,  FL  32750
Correspondent Contact JIM NEE
Regulation Number880.5200
Classification Product Code
LRS  
Date Received04/28/1993
Decision Date 08/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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