510(k) K801036 ยท FXX Mask, Surgical
SURGICAL MASK
| Applicant | American Threshold Industries, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 4, 1980 |
| Received | May 2, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2003 | Safco Dental Supply Co. Inc. Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062 Terminated |
FXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.