The following data is part of a premarket notification filed by Action Medical Systems, Inc. with the FDA for L.a.f. Isolation Pack.
| Device ID | K802885 |
| 510k Number | K802885 |
| Device Name: | L.A.F. ISOLATION PACK |
| Classification | Gown, Surgical |
| Applicant | ACTION MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1981-01-15 |