The following data is part of a premarket notification filed by Neomed, Inc. with the FDA for Neomed Sterile Syringe, Models Sd-s1eo, Sd-s3eo, Sd-s630, Sd-s12eo, Sd-s20eo, Sd-s35eo, Sd-s60eo.
| Device ID | K092908 |
| 510k Number | K092908 |
| Device Name: | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO |
| Classification | Syringe, Piston |
| Applicant | NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Contact | Penny Northcutt |
| Correspondent | Penny Northcutt NEOMED, INC. 717 LAKEGLEN DR. Suwanee, GA 30024 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-03-10 |
| Summary: | summary |