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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 K952071
Device Name ULTEC THIN HYDROCOLLOID DRESSING
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact K. MICHAEL KROEHNKE
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact K. MICHAEL KROEHNKE
Classification Product Code
MGP  
Date Received05/02/1995
Decision Date 06/22/1995
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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