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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 K952044
Device Name INSULCAP
Applicant
Karen Holtz
1606 Presidio Way
Roseville,  CA  95661
Correspondent
Karen Holtz
1606 Presidio Way
Roseville,  CA  95661
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/01/1995
Decision Date 02/13/1996
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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