The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Du Pont Xenolite(tm) Radiation Protection Apparel.
| Device ID | K896511 |
| 510k Number | K896511 |
| Device Name: | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL |
| Classification | Shield, Protective, Personnel |
| Applicant | E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Contact | Kenneth L Woodlin |
| Correspondent | Kenneth L Woodlin E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington, DE 19898 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-14 |
| Decision Date | 1989-12-22 |