510(k) K901923
K901923 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "INVOTEC POLY-MESH MANDIBULAR TRAY". The FDA issued a decision of Substantially Equivalent on October 31, 1990. The device falls under product code JAZ (Prosthesis, Facial, Mandibular Implant), a Class II device regulated under 21 CFR 874.3695. Invotec International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1990
- Date Received
- April 30, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Facial, Mandibular Implant
- Device Class
- Class II
- Regulation Number
- 874.3695
- Review Panel
- EN
- Submission Type