The following data is part of a premarket notification filed by Kentron Health Care, Inc. with the FDA for Impervious Isolation Gown.
| Device ID | K972410 |
| 510k Number | K972410 |
| Device Name: | IMPERVIOUS ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | KENTRON HEALTH CARE, INC. 3604 KELTON JACKSON ROAD Springfield, TN 37172 |
| Contact | Nari Sadarangani |
| Correspondent | Nari Sadarangani KENTRON HEALTH CARE, INC. 3604 KELTON JACKSON ROAD Springfield, TN 37172 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-09-19 |