The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Pdi Prepmaster Wet Pack Vaginal-x21477.
| Device ID | K840343 |
| 510k Number | K840343 |
| Device Name: | PDI PREPMASTER WET PACK VAGINAL-X21477 |
| Classification | Surgeon's Gloves |
| Applicant | NICE-PAK PRODUCTS, INC. 150 NORTH MACQUESTEN PKWY. Mount Vernon, NY 10550 |
| Contact | Joseph J Genovese |
| Correspondent | Joseph J Genovese NICE-PAK PRODUCTS, INC. 150 NORTH MACQUESTEN PKWY. Mount Vernon, NY 10550 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-06 |
| Decision Date | 1984-03-27 |