The following data is part of a premarket notification filed by Bio-med U.s.a., Inc. with the FDA for Bio-med Soft Insulin Syringe: Models 1cc, 0.5cc, 0.3cc.
| Device ID | K081547 |
| 510k Number | K081547 |
| Device Name: | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC |
| Classification | Syringe, Piston |
| Applicant | BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED U.S.A., INC. 111 ELLISON ST. Paterson, NJ 07505 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-09-08 |
| Summary: | summary |