The following data is part of a premarket notification filed by Triton Technology, Inc. with the FDA for Suction Guillotine Device.
Device ID | K932142 |
510k Number | K932142 |
Device Name: | SUCTION GUILLOTINE DEVICE |
Classification | Instrument, Biopsy, Suction |
Applicant | TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
Contact | William Kolozsi |
Correspondent | William Kolozsi TRITON TECHNOLOGY, INC. 2380 SOUTHEAST BLVD. Salem, OH 44460 |
Product Code | FCK |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1993-09-24 |