The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Curasorb Zn + Mg Alginate Wound Dressing.
| Device ID | K973509 |
| 510k Number | K973509 |
| Device Name: | KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Jan L Efflandt |
| Correspondent | Jan L Efflandt 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1997-12-04 |
| Summary: | summary |