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510(k) Data Aggregation
K Number
K101547Device Name
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
Manufacturer
HENKE-SASS WOLF, GMBH.
Date Cleared
2010-11-22
(172 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HENKE-SASS WOLF, GMBH.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).
Device Description
The purpose of this request is for marketing clearance of Henke-Sass, Wolf piston syringe because we have added a new purple-colored plunger for a new version of the syringe. The piston syringes covered by this submission will have the same performance as already marketed devices. The only difference will be the coloring of the plunger in adding a master batch to the original material.
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K Number
K952186Device Name
HSW GMBH HYSTEROSCOPES & ACCESSORIES
Manufacturer
HENKE-SASS WOLF, GMBH.
Date Cleared
1996-02-06
(273 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
HENKE-SASS WOLF, GMBH.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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