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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 K936261
Device Name CATHETER INSERTION TRAY
Applicant
MEDCARE CUSTOM PACKAGING, INC.
WINCHESTER ST.
WEST SWANZEY,  NH  03469 -0069
Applicant Contact WILLIAM A HAYS
Correspondent
MEDCARE CUSTOM PACKAGING, INC.
WINCHESTER ST.
WEST SWANZEY,  NH  03469 -0069
Correspondent Contact WILLIAM A HAYS
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received12/20/1993
Decision Date 03/10/1994
Decision Substantially Equivalent - Kit (SESK)
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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