The following data is part of a premarket notification filed by San-mar Laboratories, Inc. with the FDA for San-mar Labs Lubricating Jelly.
| Device ID | K041667 |
| 510k Number | K041667 |
| Device Name: | SAN-MAR LABS LUBRICATING JELLY |
| Classification | Condom |
| Applicant | SAN-MAR LABORATORIES, INC. 4 WAREHOUSE LN. Elmsford, NY 10523 |
| Contact | Simon Sanders |
| Correspondent | Simon Sanders SAN-MAR LABORATORIES, INC. 4 WAREHOUSE LN. Elmsford, NY 10523 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2005-01-13 |
| Summary: | summary |