510(k) K790607
K790607 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "GREENLINE IRRIGATION TRAYS". The FDA issued a decision of Substantially Equivalent on May 11, 1979. The device falls under product code EYN (Tray, Irrigation, Sterile), a Class II device regulated under 21 CFR 876.5980. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1979
- Date Received
- March 29, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Irrigation, Sterile
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- SU
- Submission Type