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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 K885096
Device Name PHYNE-VU
Applicant
Medical Resources, Ltd.
520 W. Brannen Rd.
Lakeland,  FL  33813
Applicant Contact RICHARD H GHENN
Correspondent
Medical Resources, Ltd.
520 W. Brannen Rd.
Lakeland,  FL  33813
Correspondent Contact RICHARD H GHENN
Classification Product Code
FRO  
Date Received12/09/1988
Decision Date 07/25/1989
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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