K945675 is an FDA 510(k) clearance for the PREPPIES SKIN BARRIER WIPE, a Dressing, Wound, Drug, submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 7, 1995, 81 days after receiving the submission on November 18, 1994. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K945675 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1994 |
| Decision Date | February 07, 1995 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |