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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 K882360
Device Name DERMAPIK
Applicant
Creative Scientific Equipment Corp.
3711 Long Beach Blvd.
Long Beach,  CA  90807
Applicant Contact PITESKY, MD
Correspondent
Creative Scientific Equipment Corp.
3711 Long Beach Blvd.
Long Beach,  CA  90807
Correspondent Contact PITESKY, MD
Regulation Number880.5570
Classification Product Code
SCL  
Date Received06/07/1988
Decision Date 08/09/1988
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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