The following data is part of a premarket notification filed by Lonza, Inc. with the FDA for Lonza Formulation R-82.
Device ID | K932502 |
510k Number | K932502 |
Device Name: | LONZA FORMULATION R-82 |
Classification | Disinfectant, Medical Devices |
Applicant | LONZA, INC. 17017 ROUTE 208 Fair Lawm, NJ 07410 |
Contact | Joseph R Robinson |
Correspondent | Joseph R Robinson LONZA, INC. 17017 ROUTE 208 Fair Lawm, NJ 07410 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-12 |
Decision Date | 1994-05-12 |