The following data is part of a premarket notification filed by Paneffort, Llc with the FDA for Paneffort Aami Level 3 Isolation Gown.
| Device ID | K212717 |
| 510k Number | K212717 |
| Device Name: | Paneffort AAMI Level 3 Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Paneffort, LLC Rochester, NY 14626 |
| Contact | Harry Harry |
| Correspondent | Shilpa Gampa Freyr Solutions 150 College Rd W #102 Princeton, NJ 08540 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-27 |
| Decision Date | 2022-11-30 |