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510(k) Submission – Olympus (K182408)
510(k) Submission – Olympus (K182408)
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510(K) Number: K182408
Device Name: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 09/04/2018
Decision Date: 05/15/2019
Regulation Medical Specialty: Gastroenterology/Urology
Request Contents: Olympus 510(k) Submission K182408
Device Name: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Manufacturer: Olympus Medical Systems Corp.
Device Classification Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation Number: 876.4300
Classification Product Code: KNS
Date Received: 09/04/2018
Decision Date: 05/15/2019
Regulation Medical Specialty: Gastroenterology/Urology
Request Contents: Olympus 510(k) Submission K182408
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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