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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 K915635
Device Name CURITY VENTED DRESSING SYSTEM
Applicant
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact PAUL EVANS
Correspondent
Kendall Healthcare Products Co. Div.Of Tyco Health
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact PAUL EVANS
Classification Product Code
MGP  
Date Received12/17/1991
Decision Date 01/31/1992
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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