The following data is part of a premarket notification filed by Davryan Laboratories, Inc. with the FDA for Probe Personal Lubricant - Classic.
| Device ID | K952464 |
| 510k Number | K952464 |
| Device Name: | PROBE PERSONAL LUBRICANT - CLASSIC |
| Classification | Condom |
| Applicant | DAVRYAN LABORATORIES, INC. 2623 S.W. PARK PL. Portland, OR 97201 |
| Contact | Bruce Campbell |
| Correspondent | Bruce Campbell DAVRYAN LABORATORIES, INC. 2623 S.W. PARK PL. Portland, OR 97201 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-26 |
| Decision Date | 1995-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B25008 | K952464 | 000 |
| B25006 | K952464 | 000 |
| B25004 | K952464 | 000 |
| B25002 | K952464 | 000 |