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510(k) K041280

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 by Felton International, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2004
Date Received
May 13, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

Other clearances by Felton International, Inc.

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