The following data is part of a premarket notification filed by Buffalo Filter Co., Inc. with the FDA for Buff. Filter Replacement Filter #bst312co,bst306co.
Device ID | K930060 |
510k Number | K930060 |
Device Name: | BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO |
Classification | Apparatus, Exhaust, Surgical |
Applicant | BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
Contact | Clinton R Holland |
Correspondent | Clinton R Holland BUFFALO FILTER CO., INC. 8388 BRIDLEWOOD DR. E. Amherst, NY 14051 |
Product Code | FYD |
CFR Regulation Number | 878.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-06 |
Decision Date | 1993-11-12 |