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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K771158
Device Name ID BRACLETS, ADULT & INFANT
Applicant
Divers-A-Med
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Divers-A-Med
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5725
Classification Product Code
LDR  
Date Received06/27/1977
Decision Date 10/13/1977
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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