510(k) K896745
K896745 is an FDA 510(k) premarket notification submitted by Plastic Engineered Products Co. for the device "JAW BLOCKER". The FDA issued a decision of Substantially Equivalent on December 14, 1989. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070. Plastic Engineered Products Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1989
- Date Received
- November 30, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Bite
- Device Class
- Class II
- Regulation Number
- 882.5070
- Review Panel
- NE
- Submission Type