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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K891288
Device Name TEGASORB(TM) ULCER DRESSING, #90-XXX
Applicant
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Applicant Contact CHARLES W OPP
Correspondent
3M Company
Chemolite Blvd. & Washington
City Rd. 19
Cottae Grove,  MN  55016
Correspondent Contact CHARLES W OPP
Classification Product Code
FRO  
Date Received03/10/1989
Decision Date 06/09/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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