The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Suction-off.
Device ID | K863653 |
510k Number | K863653 |
Device Name: | SUCTION-OFF |
Classification | Clamp |
Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Contact | Stephen W Briggs |
Correspondent | Stephen W Briggs B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Product Code | HXD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-18 |
Decision Date | 1986-10-07 |