The following data is part of a premarket notification filed by Halyard Health, Inc. with the FDA for Aero Chrome* Select Breathable Performance Surgical Gowns.
| Device ID | K162930 |
| 510k Number | K162930 |
| Device Name: | Aero Chrome* Select Breathable Performance Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | David M. Lee |
| Correspondent | David M. Lee Halyard Health, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-19 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651446986 | K162930 | 000 |
| 30680651446979 | K162930 | 000 |
| 30680651446962 | K162930 | 000 |