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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K901856
Device Name CUSTOM WOUND MANAGEMENT KITS AND TRAYS
Applicant
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Applicant Contact DAVID B PETERS
Correspondent
Medcare Custom Packaging, Inc.
Winchester St.
E Swanzey,  NH  03469
Correspondent Contact DAVID B PETERS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received04/24/1990
Decision Date 08/01/1990
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
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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