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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 K942774
Device Name POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
Applicant
The Kendal Co.
2320 Bowling Green Rd.
Franklin,  KY  42134
Applicant Contact DAVID A OLSON
Correspondent
The Kendal Co.
2320 Bowling Green Rd.
Franklin,  KY  42134
Correspondent Contact DAVID A OLSON
Classification Product Code
MGP  
Date Received06/13/1994
Decision Date 07/20/1994
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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