The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Sterile Laparotomy Sponges.
| Device ID | K890770 |
| 510k Number | K890770 |
| Device Name: | STERILE LAPAROTOMY SPONGES |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-14 |
| Decision Date | 1989-03-14 |