EPIDURAL ANESTHESIA NEEDLES

Needle, Conduction, Anesthetic (w/wo Introducer)

REGANES, INC.

The following data is part of a premarket notification filed by Reganes, Inc. with the FDA for Epidural Anesthesia Needles.

Pre-market Notification Details

• Device ID: K854816
• 510k Number: K854816
• Device Name: EPIDURAL ANESTHESIA NEEDLES
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: REGANES, INC. P.O. BOX 13212 Clearwater, FL 33519
• Contact: Joseph E Harms
• Correspondent: Joseph E Harms; REGANES, INC. P.O. BOX 13212 Clearwater, FL 33519
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-12-03
• Decision Date: 1985-12-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20809160324353	K854816	000
M661S135176008	K854816	000
M661S135175008	K854816	000
M661S135173828	K854816	000
M661S135173508	K854816	000
M661S135173008	K854816	000
M661S135144008	K854816	000
M661S135143508	K854816	000
M661S103418500	K854816	000
M661S103418350	K854816	000
M661S103417350	K854816	000
M661S075185001	K854816	000
M661S075183501	K854816	000
M661S075175001	K854816	000
M661S135183508	K854816	000
M661S885183501	K854816	000
20809160324346	K854816	000
20809160324339	K854816	000
20809160324322	K854816	000
20809160324315	K854816	000
20809160324308	K854816	000
20809160324292	K854816	000
20809160324285	K854816	000
20809160324278	K854816	000
20809160324261	K854816	000
20809160324247	K854816	000
20809160323493	K854816	000
20809160323486	K854816	000
40193489902823	K854816	000
M661S075173501	K854816	000