SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018

Instrument, Biopsy

INRAD

The following data is part of a premarket notification filed by Inrad with the FDA for Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018.

Pre-market Notification Details

• Device ID: K093256
• 510k Number: K093256
• Device Name: SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
• Classification: Instrument, Biopsy
• Applicant: INRAD 4375 DONKER COURT S.E. Kentwood, MI 49512
• Contact: Melissa Lalomia
• Correspondent: Melissa Lalomia; INRAD 4375 DONKER COURT S.E. Kentwood, MI 49512
• Product Code: KNW
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-19
• Decision Date: 2009-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10817295020715	K093256	000
10817295020623	K093256	000
10817295020630	K093256	000
10817295020647	K093256	000
10817295020654	K093256	000
10817295020661	K093256	000
10817295020678	K093256	000
10817295020685	K093256	000
10817295020692	K093256	000
10817295020708	K093256	000
10817295020616	K093256	000