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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 K811966
Device Name VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
Applicant
VISITEC CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VISITEC CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/10/1981
Decision Date 07/23/1981
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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