510(k) K760500
K760500 is an FDA 510(k) premarket notification submitted by Unimetrics Corp. for the device "TUBE, HEAVY GLASS WALL INJECTION". The FDA issued a decision of Substantially Equivalent on September 3, 1976. The device falls under product code DXL (Injector, Indicator), a Class II device regulated under 21 CFR 870.1660. Unimetrics Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1976
- Date Received
- August 23, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Indicator
- Device Class
- Class II
- Regulation Number
- 870.1660
- Review Panel
- CV
- Submission Type