510(k) K760909
K760909 is an FDA 510(k) premarket notification submitted by Plastics/Packaging for the device "THERMOMETER JARS AND CAPS". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code ELK (Teeth, Artificial, Backing And Facing), a Class I device regulated under 21 CFR 872.3910. Plastics/Packaging has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1976
- Date Received
- October 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Teeth, Artificial, Backing And Facing
- Device Class
- Class I
- Regulation Number
- 872.3910
- Review Panel
- DE
- Submission Type