510(k) K964358 ยท FXX Mask, Surgical
AMSEAL SURGICAL FACE MASK
| Applicant | American Seal Co., Hayward CA, US |
| Decision | Substantially Equivalent, Feb 14, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2013 | Maytex Corp Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA
Ear-loop face mask for ba Terminated |
FXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.