The following data is part of a premarket notification filed by String King Lacrosse, Llc with the FDA for Disposable Isolation Gown -level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-large, Blue.
| Device ID | K212633 |
| 510k Number | K212633 |
| Device Name: | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue |
| Classification | Gown, Isolation, Surgical |
| Applicant | String King Lacrosse, LLC 19100 S Vermont Ave. Gardena, CA 90248 |
| Contact | Thomas Frasca |
| Correspondent | Sharon Morrow Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-19 |
| Decision Date | 2021-11-24 |