The following data is part of a premarket notification filed by Lake Pharmaceutical, Inc. with the FDA for Lubricating Jelly.
| Device ID | K903910 |
| 510k Number | K903910 |
| Device Name: | LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | LAKE PHARMACEUTICAL, INC. 700 THIRTEENTH ST. N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Samia N Rodriguez |
| Correspondent | Samia N Rodriguez LAKE PHARMACEUTICAL, INC. 700 THIRTEENTH ST. N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1990-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00708820514591 | K903910 | 000 |