510(k) K880442
K880442 is an FDA 510(k) premarket notification submitted by Pro Care Laboratories, Inc. for the device "BRUSHRITE". The FDA issued a decision of Substantially Equivalent on May 16, 1988. The device falls under product code JEG (Analyzer, Gas, Argon, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1075.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1988
- Date Received
- February 2, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Argon, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1075
- Review Panel
- AN
- Submission Type