The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Tomac Lubricating Jelly.
| Device ID | K822143 |
| 510k Number | K822143 |
| Device Name: | TOMAC LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-21 |
| Decision Date | 1982-07-30 |