The following data is part of a premarket notification filed by Norpak Mfg., Inc. with the FDA for Alcohol Prep And Povidone-iodine Prep.
| Device ID | K896835 |
| 510k Number | K896835 |
| Device Name: | ALCOHOL PREP AND POVIDONE-IODINE PREP |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | NORPAK MFG., INC. 85 CHAMBERS DRIVE, #8 Ajax, Ontario L1z 1e2, CA |
| Contact | Michael Cruickshank |
| Correspondent | Michael Cruickshank NORPAK MFG., INC. 85 CHAMBERS DRIVE, #8 Ajax, Ontario L1z 1e2, CA |
| 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 | 1989-12-05 |
| Decision Date | 1990-01-11 |