510(k) K872656
K872656 is an FDA 510(k) premarket notification submitted by Viox Corp. for the device "LEAD GLASS SHIELDS". The FDA issued a decision of Substantially Equivalent on Jul 16, 1987. The device falls under product code IWR (Holder, Syringe, Lead), a Class I device regulated under 21 CFR 892.6500. Viox Corp. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 16, 1987
- Date Received
- Jul 7, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Holder, Syringe, Lead
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type
- 510(k) Exempt