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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Allergen And Vaccine Delivery Needles
510(k) Number K941820
Device Name DUOTIP-TEST
Applicant
Lincoln Diagnostics, Inc.
Hickory Pt. Rd. Box 1128
Decatur,  IL  62525
Applicant Contact GARY L HEIN
Correspondent
Lincoln Diagnostics, Inc.
Hickory Pt. Rd. Box 1128
Decatur,  IL  62525
Correspondent Contact GARY L HEIN
Regulation Number880.5570
Classification Product Code
SCL  
Date Received04/13/1994
Decision Date 09/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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