The following data is part of a premarket notification filed by Cryodyne Technologies, Inc. with the FDA for Ctc 30, 40, 1 Liquid Oxygen Liters.
Device ID | K860738 |
510k Number | K860738 |
Device Name: | CTC 30, 40, 1 LIQUID OXYGEN LITERS |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | CRYODYNE TECHNOLOGIES, INC. 3541 STATE RD. 710 Riviera Beach, FL 33404 |
Contact | David E Smith |
Correspondent | David E Smith CRYODYNE TECHNOLOGIES, INC. 3541 STATE RD. 710 Riviera Beach, FL 33404 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-27 |
Decision Date | 1986-08-06 |