Product code OJU— General, Plastic Surgery

“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”

FDA has cleared 1 device under product code OJU, all in 1978, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• Pharmaseal Div., Baxter Healthcare Corp.1 clearance

• K781797 — PREP TRAY, PREOPERATIVE SKINPharmaseal Div., Baxter Healthcare Corp.·1978-11-08