The following data is part of a premarket notification filed by Immuno-u.s., Inc. with the FDA for Duploject (0.5/1.0 Ml, 2.0 Ml, 5.0 Ml).
| Device ID | K973510 |
| 510k Number | K973510 |
| Device Name: | DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) |
| Classification | Syringe, Piston |
| Applicant | IMMUNO-U.S., INC. 15825 SHADY GROVE ROAD, SUITE 90 Rockville, MD 20850 |
| Contact | David West |
| Correspondent | David West IMMUNO-U.S., INC. 15825 SHADY GROVE ROAD, SUITE 90 Rockville, MD 20850 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1997-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412314112 | K973510 | 000 |
| 00085412314105 | K973510 | 000 |
| 00085412095646 | K973510 | 000 |