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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 K951149
Device Name SINGLE USE INSTRUMENT TRAY
Applicant
Medcare Custom Packaging, Inc.
234 Old Homestead Hwy.
Rte. 32
East Swanzey,  NH  03446
Applicant Contact WILLIAM A HAYS
Correspondent
Medcare Custom Packaging, Inc.
234 Old Homestead Hwy.
Rte. 32
East Swanzey,  NH  03446
Correspondent Contact WILLIAM A HAYS
Regulation Number878.4370
Classification Product Code
LRO  
Date Received03/13/1995
Decision Date 04/06/1995
Decision Substantially Equivalent - Kit (SESK)
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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