The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Preci-jet 50.
Device ID | K851181 |
510k Number | K851181 |
Device Name: | PRECI-JET 50 |
Classification | Injector, Fluid, Non-electrically Powered |
Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Contact | Tech Inc |
Correspondent | Tech Inc ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
Product Code | KZE |
CFR Regulation Number | 880.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-25 |
Decision Date | 1985-06-06 |