The following data is part of a premarket notification filed by Neilmed Pharmaceuticals, Inc. with the FDA for Woundwash Saline Spray.
| Device ID | K123910 |
| 510k Number | K123910 |
| Device Name: | WOUNDWASH SALINE SPRAY |
| Classification | Dressing, Wound, Drug |
| Applicant | NEILMED PHARMACEUTICALS, INC. 601 AVIATION BLVD. Santa Rosa, CA 95403 |
| Contact | Ketan Mehta |
| Correspondent | Ketan Mehta NEILMED PHARMACEUTICALS, INC. 601 AVIATION BLVD. Santa Rosa, CA 95403 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00705928652101 | K123910 | 000 |