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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 K914174
Device Name STERILE DISPOSABLE WET SKIN SCRUB TRAY
Applicant
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/18/1991
Decision Date 02/24/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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
Recalls CDRH Recalls
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