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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 K943057
Device Name CAP SAFE SYSTEM
Applicant
Medical Safety Solutions
1099 Mearns Rd.
Warminster,  PA  18974
Applicant Contact MICHAEL J SPADARO
Correspondent
Medical Safety Solutions
1099 Mearns Rd.
Warminster,  PA  18974
Correspondent Contact MICHAEL J SPADARO
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/31/1994
Decision Date 07/12/1995
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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