The following data is part of a premarket notification filed by Winchester Laboratories Llc. with the FDA for Saljet Single Dose Sterile Saline Topical Solution.
| Device ID | K993969 |
| 510k Number | K993969 |
| Device Name: | SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION |
| Classification | Dressing, Wound, Drug |
| Applicant | WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia, IL 60510 |
| Contact | Howard Rose |
| Correspondent | Howard Rose WINCHESTER LABORATORIES LLC. 325 NORTH WATER ST. Batavia, IL 60510 |
| 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 | 1999-11-23 |
| Decision Date | 1999-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40612479271294 | K993969 | 000 |
| 60188151000000 | K993969 | 000 |