The following data is part of a premarket notification filed by Zefon Medical Products with the FDA for Zefon Adult Anesthesia Breathing Circuit.
Device ID | K924889 |
510k Number | K924889 |
Device Name: | ZEFON ADULT ANESTHESIA BREATHING CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
Applicant | ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
Contact | Joseph Bozosi |
Correspondent | Joseph Bozosi ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
Product Code | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-28 |
Decision Date | 1993-03-19 |