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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cap, surgical
510(k) Number K800810
Device Name FLARE DIS. NONWOVEN HEAD COVERS
Applicant
FLARE PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
FLARE PRODUCTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4040
Classification Product Code
FYF  
Date Received04/10/1980
Decision Date 05/20/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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