The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Curity Iodoform Packing Strip.
| Device ID | K973763 |
| 510k Number | K973763 |
| Device Name: | KENDALL CURITY IODOFORM PACKING STRIP |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1997-12-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521068732 | K973763 | 000 |
| 20884521068725 | K973763 | 000 |
| 20884521068718 | K973763 | 000 |
| 20884521068701 | K973763 | 000 |