The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Gertie Marx Needle.
| Device ID | K943649 |
| 510k Number | K943649 |
| Device Name: | GERTIE MARX NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Fred Mitermeier |
| Correspondent | Fred Mitermeier MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-03-22 |