The following data is part of a premarket notification filed by Global Medical Products, Ltd. with the FDA for Global Medical Combined Spinal Epidural Kit (gma 1827 And Gma 1725).
| Device ID | K961444 |
| 510k Number | K961444 |
| Device Name: | GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Contact | Peter Clark |
| Correspondent | Peter Clark GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-08-01 |