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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 K952907
Device Name EX-111 WOUND DRESSING
Applicant
Variseal Manufacturing Corp.
P.O. Box 710 15547 Main
Market Rd.
Parkman,  OH  44080
Applicant Contact OWEN M GRANT, JR.
Correspondent
Variseal Manufacturing Corp.
P.O. Box 710 15547 Main
Market Rd.
Parkman,  OH  44080
Correspondent Contact OWEN M GRANT, JR.
Classification Product Code
FRO  
Date Received06/22/1995
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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