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510(k) Data Aggregation
K Number
K062261Device Name
FOAM RING PORT PROTECTOR
Manufacturer
Date Cleared
2007-04-09
(248 days)
Product Code
Regulation Number
880.5965Why did this record match?
Product Code :
OBK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin.
The device is intended to cushion the localized area surrounding the port.
Device Description
The thickness of the foam ring, along with the hole in the center of the ring, aids in preventing things, such as seat belts, bra straps, and clothing, from rubbing against the embedded port. The product consists of one element; an off-white colored flat ring made out of non-latex hypoallergenic foam, with a die cut hole in the middle, with non-latex adhesive backing.
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