The following data is part of a premarket notification filed by Nurse Assist, Inc. with the FDA for Lube Jelly Suringe.
| Device ID | K121390 |
| 510k Number | K121390 |
| Device Name: | LUBE JELLY SURINGE |
| Classification | Lubricant, Patient |
| Applicant | NURSE ASSIST, INC. 4409 Haltom Rd Haltom City, TX 76117 |
| Contact | Bill Kanewske |
| Correspondent | Bill Kanewske NURSE ASSIST, INC. 4409 Haltom Rd Haltom City, TX 76117 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-09 |
| Decision Date | 2012-08-10 |
| Summary: | summary |