The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Combosafe (europe) And Promax (us) Surgical Gowns.
| Device ID | K041540 |
| 510k Number | K041540 |
| Device Name: | COMBOSAFE (EUROPE) AND PROMAX (US) 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 | 2005-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634916343267 | K041540 | 000 |
| 00634916086676 | K041540 | 000 |
| 00634916086669 | K041540 | 000 |
| 00634916081428 | K041540 | 000 |
| 00634916042528 | K041540 | 000 |
| 00634916042511 | K041540 | 000 |
| 00634916684926 | K041540 | 000 |
| 00634916684919 | K041540 | 000 |
| 00634916684896 | K041540 | 000 |
| 10634916819042 | K041540 | 000 |
| 10634916819035 | K041540 | 000 |
| 10634916819028 | K041540 | 000 |
| 10634916825388 | K041540 | 000 |
| 10634916825371 | K041540 | 000 |
| 10634916825364 | K041540 | 000 |
| 00634916086683 | K041540 | 000 |
| 00634916139297 | K041540 | 000 |
| 00634916139303 | K041540 | 000 |
| 00634916343243 | K041540 | 000 |
| 00634916295122 | K041540 | 000 |
| 00634916295115 | K041540 | 000 |
| 00634916294972 | K041540 | 000 |
| 00634916189575 | K041540 | 000 |
| 00634916147643 | K041540 | 000 |
| 00634916147612 | K041540 | 000 |
| 00634916147599 | K041540 | 000 |
| 00634916146622 | K041540 | 000 |
| 00634916141870 | K041540 | 000 |
| 00634916141863 | K041540 | 000 |
| 00634916141801 | K041540 | 000 |
| 00634916141795 | K041540 | 000 |
| 00634916139310 | K041540 | 000 |
| 00634916795493 | K041540 | 000 |