The following data is part of a premarket notification filed by Oralabs, Inc. with the FDA for Cvs Health Dry Mouth Spray, Oralabs Dry Mouth Spray.
| Device ID | K181839 |
| 510k Number | K181839 |
| Device Name: | CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray |
| Classification | Saliva, Artificial |
| Applicant | OraLabs, Inc. 18685 East Plaza Drive Parker, CO 80134 |
| Contact | Gary Schlatter |
| Correspondent | Teresa Purdue OraLabs, Inc. 18685 East Plaza Drive Parker, CO 80134 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2019-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D132DMS0010 | K181839 | 000 |
| 00708820384446 | K181839 | 000 |
| 00050428446102 | K181839 | 000 |