510(k) K140907

Device: LEECH, MEDICINAL
Applicant: CAROLINA BIOLOGICAL SUPPLY CO.
510(k) number: K140907
Product code: NRN
Decision: Substantially Equivalent (SESE)
Decision date: 2015-08-07
Date received: 2014-04-08
Regulation: 510(k) Premarket Notification
Classification name: Leeches, Medicinal
Medical specialty: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Review panel: General & Plastic Surgery
Device class: U
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: KEITH E BARKER
Address: 2700 York Rd. Burlington NC US 27215 27215

FDA Registration Numbers#

3009106257
3008127439
2419564
1048439

Source Documents#

Other 510(k) Records For Product Code NRN #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K132958	MEDICINAL LEECHES	Biopharm (Uk) , Ltd.	2014-02-19
K040187	MEDICINAL LEECHES	Ricarimpex Sas	2004-06-21

Legacy Summary#

summary

FDA Review#

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