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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K880746
Device Name STERILE NEEDLE FOR BLOOD COLLECTION
Applicant
Applied Plastics Technology, Inc.
10400 Trademark
Rancho Cucamonga,  CA  91730
Applicant Contact ROSEANNE HIRSCH
Correspondent
Applied Plastics Technology, Inc.
10400 Trademark
Rancho Cucamonga,  CA  91730
Correspondent Contact ROSEANNE HIRSCH
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/24/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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