The following data is part of a premarket notification filed by Ultra Seal Corporation with the FDA for Ultra Seal Sterile Lubricating Jelly.
| Device ID | K101522 |
| 510k Number | K101522 |
| Device Name: | ULTRA SEAL STERILE LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | ULTRA SEAL CORPORATION 521 MAIN STREET New Paltz, NY 12561 |
| Contact | James Davis |
| Correspondent | James Davis ULTRA SEAL CORPORATION 521 MAIN STREET New Paltz, NY 12561 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-12-23 |
| Summary: | summary |