The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Isolation Mask I.c.s..
| Device ID | K831062 |
| 510k Number | K831062 |
| Device Name: | ISOLATION MASK I.C.S. |
| Classification | Chamber, Patient Isolation |
| Applicant | AMERICAN THRESHOLD INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-08 |
| Decision Date | 1983-04-13 |