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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 K922177
Device Name DISPOSABLE MULTI-PUNCTURE APPLICATOR
Applicant
Allergy Extract Co.
Mill Run Professional Parke
3760 Ridge Mill Dr.
Hilliard,  OH  43026
Applicant Contact ROBERT BALDWIN
Correspondent
Allergy Extract Co.
Mill Run Professional Parke
3760 Ridge Mill Dr.
Hilliard,  OH  43026
Correspondent Contact ROBERT BALDWIN
Regulation Number880.5570
Classification Product Code
SCL  
Date Received05/08/1992
Decision Date 06/17/1993
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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