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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name First Aid Kit With Drug
510(k) Number K896413
Device Name COMBINATION 6X-MAGNIFIER AND TWEEZERS
Applicant
James Alexander Corp.
Rd 3
Box 192
Blairstown,  NJ  07825
Applicant Contact DAVID ROBINSON
Correspondent
James Alexander Corp.
Rd 3
Box 192
Blairstown,  NJ  07825
Correspondent Contact DAVID ROBINSON
Classification Product Code
LRR  
Date Received11/08/1989
Decision Date 02/01/1990
Decision Substantially Equivalent (SESE)
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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