The following data is part of a premarket notification filed by Ispg, Inc. with the FDA for Hypodermic Syringe Piston.
Device ID | K950133 |
510k Number | K950133 |
Device Name: | HYPODERMIC SYRINGE PISTON |
Classification | Syringe, Piston |
Applicant | ISPG, INC. 517 LITCHFIELD RD. New Milford, CT 06776 |
Contact | Loretta F Luhman |
Correspondent | Loretta F 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 | 1995-01-13 |
Decision Date | 1995-04-13 |