The following data is part of a premarket notification filed by Global Medical Products, Ltd. with the FDA for Epidural Anesthesia Kit And Combined Spinal Epidural Anesthesia Kit.
| Device ID | K962821 |
| 510k Number | K962821 |
| Device Name: | EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Contact | Peter M Clark |
| Correspondent | Peter M Clark GLOBAL MEDICAL PRODUCTS, LTD. 244 MAIN ST., SOUTH P.O. BOX 505 Woodbury, CT 06798 -0505 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-19 |
| Decision Date | 1996-11-13 |