The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curity(r) Disposable Laparotomy Sponges.
| Device ID | K896490 |
| 510k Number | K896490 |
| Device Name: | CURITY(R) DISPOSABLE LAPAROTOMY SPONGES |
| Classification | Gauze/sponge, Internal |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Stephen J Tamsett |
| Correspondent | Stephen J Tamsett KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| 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 | 1989-11-13 |
| Decision Date | 1989-12-13 |