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510(k) Data Aggregation
K Number
K041084Device Name
CLIP-ON SPACER 20%; 40%; 50%
Manufacturer
Date Cleared
2004-07-15
(80 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SERONO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Clip-On Spacer is designed for use with Rebit® prefilled syringes containing The Clip-On Spacer is designed for use with Rebile pro mode of may and therapy.
The Clip-On Spacer is designed to aid the user in injecting the appropriate The Clip-On Spacer Is designed to "Blu" the "Boo" in "Myoung" when less than the full volume of the syringe is prescribed.
Device Description
The Clip-On Spacer is designed to clip around the plunger rod of the Rebit® pre-filled syringe. It is held in place using a hook-hole closure which resists opening, once closed, under axial compression of 28N. When the plunger rod is depressed into the syringe barrel, the Clip-On Spacer limits the volume of solution delivered from the syringe to within ± 1.5% of the syringe volume (1 mL) ± 2% of the expelled volume according to EN ISO 7886-1:1997 "Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use"..
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