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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K842301
Device Name DISPOSABLE LATEX BANDAGE
Applicant
Inmed Corp.
3030-B Holcomb Bridge Rd.
Norcross,  GA  30071
Applicant Contact FLO BECKER
Correspondent
Inmed Corp.
3030-B Holcomb Bridge Rd.
Norcross,  GA  30071
Correspondent Contact FLO BECKER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/11/1984
Decision Date 11/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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