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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 K953939
Device Name QUINTEST
Applicant
Bayer Corp.
3525 N. Regal St.
Spokane,  WA  99207
Applicant Contact DAVID L MIRABELL
Correspondent
Bayer Corp.
3525 N. Regal St.
Spokane,  WA  99207
Correspondent Contact DAVID L MIRABELL
Regulation Number880.5570
Classification Product Code
SCL  
Date Received08/15/1995
Decision Date 11/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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