The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Baxter Acetone-alcohol Prep Pads, Sterile.
| Device ID | K893958 |
| 510k Number | K893958 |
| Device Name: | BAXTER ACETONE-ALCOHOL PREP PADS, STERILE |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Contact | Wanda J Totton |
| Correspondent | Wanda J Totton SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Product Code | LKB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-01 |
| Decision Date | 1989-10-03 |