The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Pdi Sterile Lubricating Jelly.
| Device ID | K974768 |
| 510k Number | K974768 |
| Device Name: | PDI STERILE LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | NICE-PAK PRODUCTS, INC. TWO NICE-PAK PARK Orangeburg, NY 10962 -1376 |
| Contact | Gary Vance |
| Correspondent | Gary Vance NICE-PAK PRODUCTS, INC. TWO NICE-PAK PARK Orangeburg, NY 10962 -1376 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-01-16 |