The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Stanguard O.r. Towel Pack-4towel Pack #278220400.
| Device ID | K860447 |
| 510k Number | K860447 |
| Device Name: | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 |
| Classification | Drape, Surgical |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Jeffrey L Taylor |
| Correspondent | Jeffrey L Taylor STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-02-19 |