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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K945274
Device Name PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
Applicant
Pro-Tec Containers, Inc.
108 Commerce St.
Suite 105
Lake Mary,  FL  32746
Applicant Contact TREESA SPENCER
Correspondent
Pro-Tec Containers, Inc.
108 Commerce St.
Suite 105
Lake Mary,  FL  32746
Correspondent Contact TREESA SPENCER
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/28/1994
Decision Date 12/14/1994
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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