510(k) K932502
K932502 is an FDA 510(k) premarket notification submitted by Lonza, Inc. for the device "LONZA FORMULATION R-82". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 1994
- Date Received
- May 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Disinfectant, Medical Devices
- Device Class
- Class I
- Regulation Number
- 880.6890
- Review Panel
- HO
- Submission Type
- 510(k) Exempt