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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 K944230
Device Name DIAL MEDICAL SUPPLY SHARPS CONTAINER
Applicant
Regulatory & Marketing Services, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Applicant Contact PARTRICK J LAMB
Correspondent
Regulatory & Marketing Services, Inc.
P.O. Box 2308
1247 Florida Ave.
Palm Harbor,  FL  34682
Correspondent Contact PARTRICK J LAMB
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/31/1994
Decision Date 11/07/1994
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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