The following data is part of a premarket notification filed by Namic with the FDA for Morse Anesthesia Manifold.
Device ID | K921322 |
510k Number | K921322 |
Device Name: | MORSE ANESTHESIA MANIFOLD |
Classification | Set, Administration, Intravascular |
Applicant | NAMIC ANGIOGRAPHIC SYSTEMS DIVISION Glens Falls, NY 12801 |
Contact | James Welsh |
Correspondent | James Welsh NAMIC ANGIOGRAPHIC SYSTEMS DIVISION Glens Falls, NY 12801 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-12 |
Decision Date | 1993-07-09 |