The following data is part of a premarket notification filed by Cryodyne Technologies, Inc. with the FDA for Calibration Gas.
Device ID | K932520 |
510k Number | K932520 |
Device Name: | CALIBRATION GAS |
Classification | Gas, Calibration (specified Concentration) |
Applicant | CRYODYNE TECHNOLOGIES, INC. 67 WINTHROP RD. Chester, CT 06412 |
Contact | Vincent J Toilo |
Correspondent | Vincent J Toilo CRYODYNE TECHNOLOGIES, INC. 67 WINTHROP RD. Chester, CT 06412 |
Product Code | BXK |
CFR Regulation Number | 868.6400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-25 |
Decision Date | 1993-08-19 |