The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Safe & Soft Maxi Shileds.
| Device ID | K842837 |
| 510k Number | K842837 |
| Device Name: | SAFE & SOFT MAXI SHILEDS |
| Classification | Pad, Menstrual, Unscented |
| Applicant | IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
| Contact | Leonard L Wolfson |
| Correspondent | Leonard L Wolfson IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
| Product Code | HHD |
| CFR Regulation Number | 884.5435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-10-15 |