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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Eye
510(k) Number K883822
Device Name FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309
Applicant
Consolidated Industries of Greater Syracuse, Inc.
P.O. Box 99
Salina Station
Syracuse,  NY  13208
Applicant Contact SPEISER, PHD
Correspondent
Consolidated Industries of Greater Syracuse, Inc.
P.O. Box 99
Salina Station
Syracuse,  NY  13208
Correspondent Contact SPEISER, PHD
Regulation Number878.4440
Classification Product Code
HMP  
Date Received09/07/1988
Decision Date 11/22/1988
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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