K781797 is an FDA 510(k) clearance for the PREP TRAY, PREOPERATIVE SKIN. This device is classified as a Skin Prep Tray (Class I - General Controls, product code OJU).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 8, 1978, 16 days after receiving the submission on October 23, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
| 510(k) Number | K781797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1978 |
| Decision Date | November 08, 1978 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | OJU — Skin Prep Tray |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance |