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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Light, Surgical, Accessories
510(k) Number K810292
Device Name CAM-WRAP
Applicant
MEDLINE INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDLINE INDUSTRIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4580
Classification Product Code
FTA  
Date Received02/03/1981
Decision Date 03/04/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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