The following data is part of a premarket notification filed by Jain Surgical Equipment, Inc. with the FDA for Jain Graft Assist.
| Device ID | K904536 |
| 510k Number | K904536 |
| Device Name: | JAIN GRAFT ASSIST |
| Classification | Retainer, Surgical |
| Applicant | JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo, MI 49001 |
| Contact | Melisa Root |
| Correspondent | Melisa Root JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo, MI 49001 |
| Product Code | GCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-04 |
| Decision Date | 1990-11-29 |