The following data is part of a premarket notification filed by Safetex Corp. with the FDA for Saxon Wet Lube.
| Device ID | K900358 |
| 510k Number | K900358 |
| Device Name: | SAXON WET LUBE |
| Classification | Condom |
| Applicant | SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights, VA 23834 |
| Contact | Ronald L Davis |
| Correspondent | Ronald L Davis SAFETEX CORP. 16101 CONTINENTAL BLVD. Colonial Heights, VA 23834 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-25 |
| Decision Date | 1990-04-02 |