510(k) K791522
K791522 is an FDA 510(k) premarket notification submitted by Flow X-Ray Corp. for the device "FLOW MEDICAL X-RAY PROTECTIVE GLOVES". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code KPY (Shield, Protective, Personnel), a Class I device regulated under 21 CFR 892.6500. Flow X-Ray Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1979
- Date Received
- August 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Protective, Personnel
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type