The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Sterile O. R. Towel.
| Device ID | K861928 |
| 510k Number | K861928 |
| Device Name: | STERILE O. R. TOWEL |
| Classification | Processor, Cine Film |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Kathy Russell |
| Correspondent | Kathy Russell ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Product Code | IXX |
| CFR Regulation Number | 892.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-09 |