The following data is part of a premarket notification filed by Aor-sullivan with the FDA for Aor-sullivan Protective Overglove.
| Device ID | K893118 |
| 510k Number | K893118 |
| Device Name: | AOR-SULLIVAN PROTECTIVE OVERGLOVE |
| Classification | Accessory, Surgical Apparel |
| Applicant | AOR-SULLIVAN 10064 MESA RIDGE CT. SUITE 212 San Diego, CA 92121 |
| Contact | Mike Petersen |
| Correspondent | Mike Petersen AOR-SULLIVAN 10064 MESA RIDGE CT. SUITE 212 San Diego, CA 92121 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-06-01 |