The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Laceration Repair Tray.
| Device ID | K921988 |
| 510k Number | K921988 |
| Device Name: | LACERATION REPAIR TRAY |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Varun Soni |
| Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-28 |
| Decision Date | 1992-11-19 |