Submission Details
| 510(k) Number | K973511 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | September 17, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K973511 is an FDA 510(k) clearance for the KENDALL CURITY PETROLATUM GAUZE, a Dressing, Wound, Drug, submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on December 16, 1997, 90 days after receiving the submission on September 17, 1997. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K973511 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | September 17, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |