SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)

Needle, Conduction, Anesthetic (w/wo Introducer)

BUSSE HOSPITAL DISPOSABLES, INC.

The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Specialty Needles (spinal Needle, Pencil Point Spinal Needle, Epidural Needle).

Pre-market Notification Details

• Device ID: K061394
• 510k Number: K061394
• Device Name: SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788
• Contact: Muhamad Ansari
• Correspondent: Muhamad Ansari; BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DRIVE P.O. BOX 11067 Hauppauge, NY 11788
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-19
• Decision Date: 2006-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00849233012264	K061394	000
00849233010567	K061394	000
20849233010554	K061394	000
00849233010543	K061394	000
00849233010536	K061394	000
00849233010529	K061394	000
20849233010516	K061394	000