The following data is part of a premarket notification filed by H & P Industries, Inc. with the FDA for Gamma Radiation Sterilized Alcohol Prep Pads.
| Device ID | K860961 |
| 510k Number | K860961 |
| Device Name: | GAMMA RADIATION STERILIZED ALCOHOL PREP PADS |
| Classification | Pad, Alcohol, Device Disinfectant |
| Applicant | H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
| Contact | Joseph Dunn |
| Correspondent | Joseph Dunn H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
| 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 | 1986-03-13 |
| Decision Date | 1986-04-09 |