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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, Hydrogel Without Drug And/Or Biologic
510(k) Number K914207
Device Name CLEARSITE(R) STERILE WOUND CARE DRESSING
Applicant
Ndm Acquisition Corp.
P.O. Box 1408
3040 E. River Rd.
Dayton,  OH  45401
Applicant Contact DONALD E KOOPMAN
Correspondent
Ndm Acquisition Corp.
P.O. Box 1408
3040 E. River Rd.
Dayton,  OH  45401
Correspondent Contact DONALD E KOOPMAN
Regulation Number878.4022
Classification Product Code
NAE  
Date Received09/19/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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