The following data is part of a premarket notification filed by Baker-sundt Research, Inc. with the FDA for Surgical Suction Apparatus.
Device ID | K895670 |
510k Number | K895670 |
Device Name: | SURGICAL SUCTION APPARATUS |
Classification | Cannula, Surgical, General & Plastic Surgery |
Applicant | BAKER-SUNDT RESEARCH, INC. 2970 N. CALLE LADERA Tucson, AZ 85715 |
Contact | Sundt, Jr |
Correspondent | Sundt, Jr BAKER-SUNDT RESEARCH, INC. 2970 N. CALLE LADERA Tucson, AZ 85715 |
Product Code | GEA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-19 |
Decision Date | 1989-09-27 |