The following data is part of a premarket notification filed by Standard Textile Co., Inc. with the FDA for Barrier Supreme Sterilization Wrapper.
| Device ID | K162162 |
| 510k Number | K162162 |
| Device Name: | Barrier Supreme Sterilization Wrapper |
| Classification | Wrap, Sterilization |
| Applicant | Standard Textile Co., Inc. One Knollcrest Drive Cincinnati, OH 45237 |
| Contact | Bradley J. Bushman |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 -1109 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634916343137 | K162162 | 000 |
| 00634916000948 | K162162 | 000 |
| 00634916000931 | K162162 | 000 |
| 00634916000924 | K162162 | 000 |
| 00634916000917 | K162162 | 000 |
| 00634916000900 | K162162 | 000 |
| 00634916000894 | K162162 | 000 |
| 00634916000887 | K162162 | 000 |
| 00634916000870 | K162162 | 000 |
| 00634916000863 | K162162 | 000 |
| 00634916000856 | K162162 | 000 |
| 00634916000955 | K162162 | 000 |
| 00634916000962 | K162162 | 000 |
| 00634916000979 | K162162 | 000 |
| 00634916343120 | K162162 | 000 |
| 00634916343113 | K162162 | 000 |
| 00634916134209 | K162162 | 000 |
| 00634916074970 | K162162 | 000 |
| 00634916005554 | K162162 | 000 |
| 00634916005547 | K162162 | 000 |
| 00634916005530 | K162162 | 000 |
| 00634916005523 | K162162 | 000 |
| 00634916005516 | K162162 | 000 |
| 00634916000986 | K162162 | 000 |
| 00634916000849 | K162162 | 000 |