The following data is part of a premarket notification filed by Hakko Shoji Co., Ltd. with the FDA for Tuohy Epidural Needles.
| Device ID | K961152 |
| 510k Number | K961152 |
| Device Name: | TUOHY EPIDURAL 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14526737171101 | K961152 | 000 |
| 14526737170913 | K961152 | 000 |
| 14526737170906 | K961152 | 000 |
| 14526737170890 | K961152 | 000 |
| 14526737170883 | K961152 | 000 |
| 14526737170876 | K961152 | 000 |
| 14526737170869 | K961152 | 000 |
| 14526737170852 | K961152 | 000 |
| 14526737170845 | K961152 | 000 |
| 04526737170831 | K961152 | 000 |
| 14526737170821 | K961152 | 000 |
| 14526737170814 | K961152 | 000 |
| 14526737170807 | K961152 | 000 |
| 14526737170791 | K961152 | 000 |
| 14526737170784 | K961152 | 000 |
| 14526737170777 | K961152 | 000 |
| 14526737170920 | K961152 | 000 |
| 14526737170937 | K961152 | 000 |
| 14526737170944 | K961152 | 000 |
| 14526737171095 | K961152 | 000 |
| 14526737171088 | K961152 | 000 |
| 14526737171071 | K961152 | 000 |
| 14526737171064 | K961152 | 000 |
| 14526737171057 | K961152 | 000 |
| 14526737171040 | K961152 | 000 |
| 14526737171033 | K961152 | 000 |
| 14526737171026 | K961152 | 000 |
| 14526737171019 | K961152 | 000 |
| 14526737171002 | K961152 | 000 |
| 14526737170999 | K961152 | 000 |
| 14526737170982 | K961152 | 000 |
| 14526737170975 | K961152 | 000 |
| 14526737170968 | K961152 | 000 |
| 14526737170951 | K961152 | 000 |
| 14526737170760 | K961152 | 000 |