510(k) K853451
K853451 is an FDA 510(k) premarket notification submitted by Trollplast, Inc. for the device "TROLL-BITE". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1986
- Date Received
- August 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Film, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1905
- Review Panel
- DE
- Submission Type