510(k) K902883
K902883 is an FDA 510(k) premarket notification submitted by Triton Technology, Inc. for the device "TISSUE/POLYP TRAP SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code BYZ (Trap, Sterile Specimen), a Class II device regulated under 21 CFR 880.6740. Triton Technology, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1990
- Date Received
- July 2, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trap, Sterile Specimen
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type