Panels › General, Plastic Surgery › Product code LYU · Class 1
Accessory, Surgical Apparel
Regulation 878.4040
0510(k)s in 12 months (56 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in LYU
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardinal Health 200, LLC | 0 | 6 |
| Medical Armor Corp. | 5 | 0 |
| Sloan Corp. | 3 | 0 |
| Wells Lamont Corp. | 3 | 0 |
| Aor-Sullivan | 2 | 0 |
| Depuy-Raynham | 2 | 0 |
| Derekduck Industries Corp. | 2 | 0 |
| Instrument Makar, Inc. | 2 | 0 |
| Lovell-Schenck, Inc. | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 1990 | K900310 | REPEL SURGICAL GLOVE LINERS Depuy-Raynham | LYU |
| Aug 11, 1989 | K894064 | STERILE HAND COVER Sage Products, Inc. | LYU |
| Aug 2, 1989 | K893842 | CYSTO APRONS IN VARIOUS SIZES Bemiss Jason Corp. | LYU |
| Jun 1, 1989 | K893118 | AOR-SULLIVAN PROTECTIVE OVERGLOVE Aor-Sullivan | LYU |
| Oct 11, 1988 | K880440 | PROTECT-AIDS AUTOPSY UNDERGLOVE Medical Armor Corp. | LYU |
| Oct 11, 1988 | K880439 | PROTECT-AIDS UNDERGLOVE Medical Armor Corp. | LYU |
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