The following data is part of a premarket notification filed by James River Corp. with the FDA for Caretex Isolution Gowns.
| Device ID | K864479 |
| 510k Number | K864479 |
| Device Name: | CARETEX ISOLUTION GOWNS |
| Classification | Gown, Isolation, Surgical |
| Applicant | JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Contact | Richard L Davis |
| Correspondent | Richard L Davis JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-13 |
| Decision Date | 1986-12-09 |