The following data is part of a premarket notification filed by James River Corp. with the FDA for Caretex Surgeon's Caps.
| Device ID | K880481 |
| 510k Number | K880481 |
| Device Name: | CARETEX SURGEON'S CAPS |
| Classification | Cap, 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 | FYF |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-02-24 |