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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 And Burn, Occlusive
510(k) Number K943363
Device Name CUTIPLAST STERIL
Applicant
Beiersdorf, Inc.
360 Dr. Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact ELIZABETH H ANDERSON
Correspondent
Beiersdorf, Inc.
360 Dr. Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact ELIZABETH H ANDERSON
Classification Product Code
MGP  
Date Received07/13/1994
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
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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