The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curasalt Hypertonic Saline Dressing.
| Device ID | K942459 |
| 510k Number | K942459 |
| Device Name: | CURASALT HYPERTONIC SALINE DRESSING |
| Classification | Bandage, Liquid |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | David A Olson |
| Correspondent | David A Olson KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-24 |
| Decision Date | 1994-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884527016669 | K942459 | 000 |