510(k) K972778
K972778 is an FDA 510(k) premarket notification submitted by Dey Laboratories, Inc. for the device "DEY VIAL SODIUM CHLORIDE 3%". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Dey Laboratories, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1997
- Date Received
- July 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type