The following data is part of a premarket notification filed by Clay-park Labs, Inc. with the FDA for Clay-park Labs, Inc. - Lubricating Jelly.
| Device ID | K012203 |
| 510k Number | K012203 |
| Device Name: | CLAY-PARK LABS, INC. - LUBRICATING JELLY |
| Classification | Lubricant, Personal |
| Applicant | CLAY-PARK LABS, INC. 1800 MASSACHUSETTS AVE., N.W. Washington, DC 20036 |
| Contact | Gary L Yingling |
| Correspondent | Gary L Yingling CLAY-PARK LABS, INC. 1800 MASSACHUSETTS AVE., N.W. Washington, DC 20036 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00311917205052 | K012203 | 000 |
| 10036800234762 | K012203 | 000 |
| 10041163250922 | K012203 | 000 |
| 00041520314307 | K012203 | 000 |
| 00070030147655 | K012203 | 000 |
| 20321130780247 | K012203 | 000 |
| 03700301471826 | K012203 | 000 |
| 20041260332252 | K012203 | 000 |
| 10719283168341 | K012203 | 000 |
| 10311917206551 | K012203 | 000 |
| 10041415055756 | K012203 | 000 |
| 10370030659798 | K012203 | 000 |