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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 K863514
Device Name PROMEDICOR
Applicant
Terra Marketing Assoc.
Waterbury Plz., Suite A
5620 S. 1475 E.
Salt Lake City,  UT  84121
Applicant Contact LANNY M HANSEN
Correspondent
Terra Marketing Assoc.
Waterbury Plz., Suite A
5620 S. 1475 E.
Salt Lake City,  UT  84121
Correspondent Contact LANNY M HANSEN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/09/1986
Decision Date 09/25/1986
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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