The following data is part of a premarket notification filed by Hammer-plane, Inc. with the FDA for Anti-disconnection Mechanism.
Device ID | K933781 |
510k Number | K933781 |
Device Name: | ANTI-DISCONNECTION MECHANISM |
Classification | Device, Fixation, Tracheal Tube |
Applicant | HAMMER-PLANE, INC. 4025 YUMA ST. Simi Valley, CA 93063 |
Contact | David Delaplane |
Correspondent | David Delaplane HAMMER-PLANE, INC. 4025 YUMA ST. Simi Valley, CA 93063 |
Product Code | CBH |
CFR Regulation Number | 868.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-04 |
Decision Date | 1993-09-22 |