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510(k) Data Aggregation
K Number
K230287Device Name
SaviSafe Safety Device
Manufacturer
Suzhou Savicred Biotechnology Co., Ltd.
Date Cleared
2023-11-21
(292 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Savicred Biotechnology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Device Description
The proposed device, Savisafe Safety Device is a non-sterile, single use anti-needlestick accessory for pre-filled ISO standard glass syringe that are 1ml with a needle length of 1/2". The proposed device consists of four components:(1) Syringe sleeve, (2) Syringe holder, (3) Plunger rod. (4) Spring. The proposed device has a five-year shelf life.
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