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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 K865089
Device Name FERRIS DYNADERM PLUS
Applicant
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Applicant Contact ROBERT W SESSIONS
Correspondent
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Correspondent Contact ROBERT W SESSIONS
Classification Product Code
FRO  
Date Received12/30/1986
Decision Date 02/04/1987
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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