The following data is part of a premarket notification filed by Strukmyer Medical Llc with the FDA for Usp Sterile Water, 120 Ml Cup, Usp Sterile Normal Saline (0.9% Sodium Chloride), 120 Ml Cup, Usp Sterile Water, 100 Ml,250 Ml And 500 Ml Bottles, Usp Sterile Normal Saline (0.9% Sodium Chloride), 100 Ml, 250 Ml And 500 Ml Bottles.
| Device ID | K161311 |
| 510k Number | K161311 |
| Device Name: | USP Sterile Water, 120 ML Cup, USP Sterile Normal Saline (0.9% Sodium Chloride), 120 ML Cup, USP Sterile Water, 100 ML,250 ML And 500 ML Bottles, USP Sterile Normal Saline (0.9% Sodium Chloride), 100 ML, 250 ML And 500 ML Bottles |
| Classification | Dressing, Wound, Drug |
| Applicant | STRUKMYER MEDICAL LLC 1801 BIG TOWN SUITE 100 Mesquite, TX 75149 |
| Contact | Robert Delk |
| Correspondent | Richard Hamer RICHARD HAMER ASSOCIATES LLC 705 SPRING LAKES BLVD Bradenton, FL 34210 |
| 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 | 2016-05-10 |
| Decision Date | 2016-08-29 |
| Summary: | summary |