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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 K990371
Device Name DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
Applicant
Post Medical, Inc.
P.O. Box 29863
Atlanta,  GA  30359
Applicant Contact DAVID R THEAD
Correspondent
Post Medical, Inc.
P.O. Box 29863
Atlanta,  GA  30359
Correspondent Contact DAVID R THEAD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/08/1999
Decision Date 04/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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