The following data is part of a premarket notification filed by James River Corp. with the FDA for Caretex Surgeon's Hoods.
| Device ID | K880431 |
| 510k Number | K880431 |
| Device Name: | CARETEX SURGEON'S HOODS |
| Classification | Hood, 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 | FXY |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-01 |
| Decision Date | 1988-02-24 |