The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Compel Mlr Surgical Gowns.
| Device ID | K041541 |
| 510k Number | K041541 |
| Device Name: | COMPEL MLR SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Contact | Bradley J Bushman |
| Correspondent | Bradley J Bushman STANDARD TEXTILE CO., INC. ONE KNOLLCREST DR. Cincinnati, OH 45237 -1600 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-08 |
| Decision Date | 2005-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810019801549 | K041541 | 000 |
| 00634916009620 | K041541 | 000 |
| 00634916010275 | K041541 | 000 |
| 00634916010282 | K041541 | 000 |
| 00634916011128 | K041541 | 000 |
| 00634916011135 | K041541 | 000 |
| 00634916011432 | K041541 | 000 |
| 00634916011814 | K041541 | 000 |
| 00634916011821 | K041541 | 000 |
| 00634916009613 | K041541 | 000 |
| 00634916709674 | K041541 | 000 |
| 00634916496963 | K041541 | 000 |
| 00810019801556 | K041541 | 000 |
| 10634916797159 | K041541 | 000 |
| 10634916797166 | K041541 | 000 |
| 10634916797173 | K041541 | 000 |
| 00810019801440 | K041541 | 000 |
| 00810019801488 | K041541 | 000 |
| 00634916496949 | K041541 | 000 |
| 00634916496956 | K041541 | 000 |
| 00634916011838 | K041541 | 000 |
| 00634916028058 | K041541 | 000 |
| 00634916191899 | K041541 | 000 |
| 00634916247305 | K041541 | 000 |
| 00634916249101 | K041541 | 000 |
| 00634916294880 | K041541 | 000 |
| 00634916296884 | K041541 | 000 |
| 00634916298673 | K041541 | 000 |
| 00634916298765 | K041541 | 000 |
| 00634916310245 | K041541 | 000 |
| 00634916191769 | K041541 | 000 |
| 00634916187618 | K041541 | 000 |
| 00634916187601 | K041541 | 000 |
| 00634916074093 | K041541 | 000 |
| 00634916074109 | K041541 | 000 |
| 00634916088526 | K041541 | 000 |
| 00634916098396 | K041541 | 000 |
| 00634916110982 | K041541 | 000 |
| 00634916110999 | K041541 | 000 |
| 00634916178968 | K041541 | 000 |
| 00634916187595 | K041541 | 000 |
| 00634916311921 | K041541 | 000 |