510(k) K892791
K892791 is an FDA 510(k) premarket notification submitted by Union Industrial Co., Ltd. for the device "PATIENT EXAMINATION GLOVES (LATEX)". The FDA issued a decision of Substantially Equivalent on August 24, 1989. The device falls under product code IMM (Footrest, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Union Industrial Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1989
- Date Received
- April 11, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Footrest, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3920
- Review Panel
- PM
- Submission Type