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510(k) K864294

HENKE-JECT PRESSURE SYRINGE (MODIFICATION) by Smith & Nephew, Inc. — Product Code EGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
October 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Jet, Mechanical-Powered
Device Class
Class II
Regulation Number
872.4475
Review Panel
DE
Submission Type

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  • K790193 — MIZZY SYRIJET MARK IV (April 23, 1979)