SPINAL NEEDLES

Needle, Conduction, Anesthetic (w/wo Introducer)

HAKKO SHOJI CO., LTD.

The following data is part of a premarket notification filed by Hakko Shoji Co., Ltd. with the FDA for Spinal Needles.

Pre-market Notification Details

• Device ID: K961151
• 510k Number: K961151
• Device Name: SPINAL NEEDLES
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: HAKKO SHOJI CO., LTD. 3726 LONSDALE AVE. Cincinnati, OH 45227
• Contact: John Rogers
• Correspondent: John Rogers; HAKKO SHOJI CO., LTD. 3726 LONSDALE AVE. Cincinnati, OH 45227
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-22
• Decision Date: 1997-03-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04526737170114	K961151	000
04526737120409	K961151	000
04526737120393	K961151	000
04526737120386	K961151	000
04526737120379	K961151	000
04526737120362	K961151	000
04526737120355	K961151	000
04526737120348	K961151	000
04526737120331	K961151	000
04526737120324	K961151	000
04526737120317	K961151	000
14526737120413	K961151	000
04526737170008	K961151	000
04526737170107	K961151	000
04526737170091	K961151	000
04526737170084	K961151	000
04526737170077	K961151	000
04526737170060	K961151	000
04526737170053	K961151	000
04526737170046	K961151	000
04526737170039	K961151	000
04526737170022	K961151	000
04526737170015	K961151	000
04526737120300	K961151	000
04526737120294	K961151	000
04526737120164	K961151	000
04526737120157	K961151	000
04526737120140	K961151	000
04526737120133	K961151	000
04526737120126	K961151	000
04526737120119	K961151	000
04526737120102	K961151	000
04526737120096	K961151	000
14526737120086	K961151	000
04526737120072	K961151	000
04526737120171	K961151	000
04526737120188	K961151	000
04526737120287	K961151	000
04526737120270	K961151	000
04526737120263	K961151	000
04526737120256	K961151	000
04526737120249	K961151	000
04526737120232	K961151	000
04526737120225	K961151	000
04526737120218	K961151	000
04526737120201	K961151	000
04526737120195	K961151	000
14526737120062	K961151	000
04526737170121	K961151	000
14526737170609	K961151	000
14526737170470	K961151	000
14526737170463	K961151	000
14526737170456	K961151	000
14526737170449	K961151	000
14526737170432	K961151	000
14526737170425	K961151	000
04526737170411	K961151	000
04526737170404	K961151	000
04526737170398	K961151	000
14526737170388	K961151	000
14526737170487	K961151	000
14526737170494	K961151	000
14526737170593	K961151	000
14526737170586	K961151	000
14526737170579	K961151	000
14526737170562	K961151	000
14526737170555	K961151	000
14526737170548	K961151	000
14526737170531	K961151	000
14526737170524	K961151	000
14526737170517	K961151	000
14526737170500	K961151	000
14526737170371	K961151	000
14526737170364	K961151	000
04526737170237	K961151	000
04526737170220	K961151	000
04526737170213	K961151	000
04526737170206	K961151	000
04526737170190	K961151	000
04526737170183	K961151	000
14526737170173	K961151	000
04526737170169	K961151	000
04526737170152	K961151	000
04526737170145	K961151	000
04526737170244	K961151	000
04526737170251	K961151	000
14526737170357	K961151	000
14526737170340	K961151	000
14526737170333	K961151	000
04526737170329	K961151	000
04526737170312	K961151	000
04526737170305	K961151	000
04526737170299	K961151	000
04526737170282	K961151	000
04526737170275	K961151	000
04526737170268	K961151	000
04526737170138	K961151	000