The following data is part of a premarket notification filed by Zefon Medical Products with the FDA for Adult Anesthesia Breathing Circuit Kits.
| Device ID | K934462 |
| 510k Number | K934462 |
| Device Name: | ADULT ANESTHESIA BREATHING CIRCUIT KITS |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Contact | Robert L Stone |
| Correspondent | Robert L Stone ZEFON MEDICAL PRODUCTS 5350 SOUTHWEST FIRST LN. Ocala, FL 34474 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-13 |
| Decision Date | 1994-03-01 |