The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for Cidex Formula 7* Long-life Activated Dialdehyde.
Device ID | K924334 |
510k Number | K924334 |
Device Name: | CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE |
Classification | Sterilant, Medical Devices |
Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Contact | T. M Wenft |
Correspondent | T. M Wenft JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
Product Code | MED |
CFR Regulation Number | 880.6885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-27 |
Decision Date | 1994-03-29 |