The following data is part of a premarket notification filed by Triton Technology, Inc. with the FDA for Tissue/polyp Trap System.
| Device ID | K902883 |
| 510k Number | K902883 |
| Device Name: | TISSUE/POLYP TRAP SYSTEM |
| Classification | Trap, Sterile Specimen |
| Applicant | TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
| Contact | Z Kolozsi,md |
| Correspondent | Z Kolozsi,md TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
| Product Code | BYZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-02 |
| Decision Date | 1990-09-12 |