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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 K952518
Device Name SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE
Applicant
Medi-Dose, Inc.
1671 Loretta Ave.
Feasterville,  PA  19053
Applicant Contact ROBERT BRAVEMAN
Correspondent
Medi-Dose, Inc.
1671 Loretta Ave.
Feasterville,  PA  19053
Correspondent Contact ROBERT BRAVEMAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/17/1995
Decision Date 07/28/1995
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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