The following data is part of a premarket notification filed by Medspec Corp. with the FDA for Sterile Isolation Gown.
| Device ID | K801069 |
| 510k Number | K801069 |
| Device Name: | STERILE ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | MEDSPEC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-06 |
| Decision Date | 1980-05-20 |