The following data is part of a premarket notification filed by San-mar Laboratories, Inc. with the FDA for Cvs Personal Lubricant.
| Device ID | K983216 |
| 510k Number | K983216 |
| Device Name: | CVS PERSONAL LUBRICANT |
| Classification | Condom |
| Applicant | SAN-MAR LABORATORIES, INC. 4 WAREHOUSE LN. Elmsford, NY 10523 |
| Contact | Irwin Silverberg |
| Correspondent | Irwin Silverberg SAN-MAR LABORATORIES, INC. 4 WAREHOUSE LN. Elmsford, NY 10523 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1999-05-17 |
| Summary: | summary |