The following data is part of a premarket notification filed by Jain Surgical Equipment, Inc. with the FDA for Jain Suture Package Counter.
| Device ID | K911077 |
| 510k Number | K911077 |
| Device Name: | JAIN SUTURE PACKAGE COUNTER |
| Classification | Container, Sharps |
| Applicant | JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo, MI 49001 |
| Contact | Melisa M Root |
| Correspondent | Melisa M Root JAIN SURGICAL EQUIPMENT, INC. 7829 SPRINKLE RD. Kalamazoo, MI 49001 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-05-31 |