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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 K935916
Device Name LIP GRIP CAP HOLDER
Applicant
Daryl C. Fallas
P.O. Box 123
77 Parker Ave.
Deal,  NJ  07723
Applicant Contact DARYL FALLAS
Correspondent
Daryl C. Fallas
P.O. Box 123
77 Parker Ave.
Deal,  NJ  07723
Correspondent Contact DARYL FALLAS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/09/1993
Decision Date 11/03/1995
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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