The following data is part of a premarket notification filed by Ispg, Inc. with the FDA for Glass Syringe.
| Device ID | K962042 |
| 510k Number | K962042 |
| Device Name: | GLASS SYRINGE |
| Classification | Syringe, Piston |
| Applicant | ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
| Contact | Loretta Luhman |
| Correspondent | Loretta Luhman ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193493924216 | K962042 | 000 |