510(k) K132958

Device: MEDICINAL LEECHES
Applicant: BIOPHARM (UK) LTD.
510(k) number: K132958
Product code: NRN
Decision: Substantially Equivalent (SESE)
Decision date: 2014-02-19
Date received: 2013-09-20
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: Bethany Sawyer
Address: 2 Bryngwili Rd. Hendy GB SA4 0XT SA4 0XT

FDA Registration Numbers#

3009106257
3008127439
1048439
2419564

Source Documents#

Other 510(k) Records For Product Code NRN #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140907	LEECH, MEDICINAL	Carolina Biological Supply Co.	2015-08-07
K040187	MEDICINAL LEECHES	Ricarimpex Sas	2004-06-21

Legacy Summary#

summary

FDA Review#

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